BD Introsyte-N, BD Instaflash 384021Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 50382903840217), received between Nov 16, 2017 and Aug 28, 2025 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (19 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Material Separation; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916533 ↗
• MalfunctionAug 28, 2025Material Separation; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916514 ↗
• MalfunctionAug 4, 2025Defective Component; Defective Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22703446 ↗
• MalfunctionJul 21, 2025Defective Component; Defective Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559702 ↗
• MalfunctionJul 13, 2025Break; Break

  CUSTOMER RESPONSE ON 14-JUL-2025. WHILE THE SAFETY INCIDENT INCLUDES DETAILS ABOUT THE ASSOCIATED CENTRAL LINE, THE INTRODUCER FAILED TO SPLIT AS EXPECTED DURING LINE INSERTION. THIS RESULTED IN DIFFICULTY REMOVING THE INTRODUCER (BD PRODUCT) FROM AROUND THE PICC LINE, CAUSING DAMAGE TO THE PICC LINE AND SUBSEQUENT NEW LINE INSERTION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22490742 ↗
• MalfunctionApr 30, 2025Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937918 ↗
• MalfunctionNov 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BD INTRODUCER INTROSYTE-N 1.9F 1.9CM CATHETER WAS DEFECTIVE/DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; IT WAS REPORTED BY CUSTOMER THAT " AFTER PICC INSERTION THROUGH AN INTRODUCER, I ATTEMPTED TO "PEEL" THE INTRODUCER BACK TO REMOVE IT OFF OF THE PICC CATHETER AND ONE SIDE STUCK TO THE CATHETER CAUSING DIFFICULTY REMOVING THE REMAINING INTRODUCER FRAGMENTS OFF THE PICC CATHETER POTENTIALLY CAUSING DAMAGE TO THE PICC CATHETER" VERBATIM FROM THE CUSTOMER: " AFTER PICC INSERTION THROUGH AN INTRODUCER, I ATTEMPTED TO "PEEL" THE INTRODUCER BACK TO REMOVE IT OFF OF THE PICC CATHETER AND ONE SIDE STUCK TO THE CATHETER CAUSING DIFFICULTY REMOVING THE REMAINING INTRODUCER FRAGMENTS OFF THE PICC CATHETER POTENTIALLY CAUSING DAMAGE TO THE PICC CATHETER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242665 ↗
• InjurySep 6, 2023Break; Break

  IT WAS REPORTED THAT THE 26 G (1.9 FR) X 1.9 CM BD INTROSYTE-N¿ PRECISION INTRODUCER BROKE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: NURSE REQUESTING TROUBLESHOOTING ASSISTANCE ON REMOVING A INTROSYTE AUTOGARD INTRODUCER THAT HAS BROKEN. SHE STATES PART OF THE INTRODUCER TIP HAS BROKEN AND IS STILL VISIBLE UNDER THE PATIENT'S SKIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17692930 ↗
• MalfunctionSep 5, 2023Defective Component; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL #: 384021 BATCH #: N/A. IT WAS REPORTED BY THE CUSTOMER THAT ONE WING BROKE OFF WHEN AN ATTEMPT WAS MADE TO PEEL THE SHEATH. VERBATIM: EVENTS THAT OCCURRED: LINE WAS INTRODUCED AS EXPECTED- IMMEDIATE FLASH OBTAINED, ADVANCED A SMALL AMOUNT MORE THEN NEEDLE REMOVED: CATHETER EASY TO THREAD, TOTAL LENGTH NEEDED TO THREAD WAS 12 CM AND CATHETER WAS TRIMMED. NP STOPPED THREADING CATHETER AT THE 10 CM MARK AND WAS ABLE TO WITHDRAW THE INTRODUCER SHEATH FROM THE SKIN. ONCE WITHDRAWN, NP ATTEMPTED TO BREAK AWAY THE SHEATH BY BRINGING THE WINGS UP AND DOWN TO SPLIT THEM APART. THE WINGS SEEMED STIFF AND WOULD NOT MORE UP OR DOWN. THEN AN ATTEMPT WAS MADE TO PEEL THE SHEATH THIS IS WHEN THE ONE WING BROKE OFF. THIS WAS ALL OUTSIDE OF THE PATIENT. OUTCOME: INITIALLY SECURED THE INTRODUCER AND ALL THEN IT BECAME NECESSARY TO REMOVE THE ENTIRE LINE. THE LINE AND INTRODUCER PLACED IN A BIOHAZARD BAG FOR STORED FOR INSPECTION. RESPONSE RECEIVED ON 13-SEP-2023: 1. ARE YOU ABLE TO PROVIDE THE DATE OF INCIDENT? 8/19/2023. 2. ARE YOU ABLE TO CONFIRM THE QUANTITY OF DEFECTIVE PRODUCT INSPECTED? ONLY 1 INTRODUCER WAS FOUND TO BE DEFECTIVE, HOWEVER WE DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687530 ↗
• MalfunctionJun 8, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD INTROSYTE-N¿ PRECISION INTRODUCER RIGHT WING BROKE OFF. THIS IS 2 OF 3 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM ONE OF THE NICU LINE INSERTION NURSES AT COOK CHILDREN¿S AND I AM REACHING OUT REGARDING OUR NEOPICC INTRODUCERS (26G 1.9FR BD INTROSYTE-N). I AM INCLUDING MY PARTNER, ON THIS EMAIL AS WELL. IN THE PAST FEW WEEKS WE HAVE HAD THREE INSTANCES WHERE THE INTRODUCER DID NOT BREAK-AWAY/SEPARATE APPROPRIATELY AS DESIGNED, ONE OF WHICH RESULTED IN HAVING TO REPLACE THE NEWLY INSERTED PICC. ADDITIONAL INFORMATION RECEIVED: HERE IS THE INFORMATION REGARDING THE RECENT INCIDENTS WE HAVE HAD REGARDING THE PICC INTRODUCERS BREAKING. ALL THREE INTRODUCERS BROKE AT THE SAME SPOT. THE RIGHT WING BROKE OFF COMPLETELY, INSTEAD OF BREAKING DOWN THE CENTER OF THE INTRODUCER IN ORDER TO PEEL IT AWAY. I¿VE INCLUDED A PICTURE BELOW-THIS WAS FROM THE FIRST PATIENT, THAT OCCURRED ON (B)(6) 2023. ARE YOU ABLE TO PROVIDE THE INCIDENT DATES FOR THE THREE INSTANCES? (B)(6) 2023. ARE YOU ABLE TO PROVIDE ANY PATIENT IDENTIFIERS INCLUDING: AGE/ DATE OF BIRTH, SEX, WEIGHT, ETHNICITY, RACE, OTHER RELEVANT HISTORY INCLUDING PREEXISTIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17089221 ↗
• MalfunctionJun 8, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD INTROSYTE-N¿ PRECISION INTRODUCER RIGHT WING BROKE OFF. THIS IS 3 OF 3 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM ONE OF THE NICU LINE INSERTION NURSES AT COOK CHILDREN¿S AND I AM REACHING OUT REGARDING OUR NEOPICC INTRODUCERS (26G 1.9FR BD INTROSYTE-N). I AM INCLUDING MY PARTNER, XXX ON THIS EMAIL AS WELL. IN THE PAST FEW WEEKS WE HAVE HAD THREE INSTANCES WHERE THE INTRODUCER DID NOT BREAK-AWAY/SEPARATE APPROPRIATELY AS DESIGNED, ONE OF WHICH RESULTED IN HAVING TO REPLACE THE NEWLY INSERTED PICC. ADDITIONAL INFORMATION RECEIVED HERE IS THE INFORMATION REGARDING THE RECENT INCIDENTS WE HAVE HAD REGARDING THE PICC INTRODUCERS BREAKING. ALL THREE INTRODUCERS BROKE AT THE SAME SPOT. THE RIGHT WING BROKE OFF COMPLETELY, INSTEAD OF BREAKING DOWN THE CENTER OF THE INTRODUCER IN ORDER TO PEEL IT AWAY. I¿VE INCLUDED A PICTURE BELOW-THIS WAS FROM THE FIRST PATIENT, THAT OCCURRED ON (B)(6)23. ARE YOU ABLE TO PROVIDE THE INCIDENT DATES FOR THE THREE INSTANCES? (B)(6)23 (B)(6)23 (B)(6)23 ARE YOU ABLE TO PROVIDE ANY PATIENT IDENTIFIERS INCLUDING: AGE/ DATE OF BIRTH, SEX, WEIGHT, ETHNICITY, RACE, OTHER RELEVANT HISTORY INCLUD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17089184 ↗
• MalfunctionJun 7, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD INTROSYTE-N¿ PRECISION INTRODUCER RIGHT WING BROKE OFF. THIS IS 1 OF 3 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM ONE OF THE NICU LINE INSERTION NURSES AT COOK CHILDREN¿S AND I AM REACHING OUT REGARDING OUR NEOPICC INTRODUCERS (26G 1.9FR BD INTROSYTE-N). I AM INCLUDING MY PARTNER, XXX ON THIS EMAIL AS WELL. IN THE PAST FEW WEEKS WE HAVE HAD THREE INSTANCES WHERE THE INTRODUCER DID NOT BREAK-AWAY/SEPARATE APPROPRIATELY AS DESIGNED, ONE OF WHICH RESULTED IN HAVING TO REPLACE THE NEWLY INSERTED PICC. ADDITIONAL INFORMATION RECEIVED: HERE IS THE INFORMATION REGARDING THE RECENT INCIDENTS WE HAVE HAD REGARDING THE PICC INTRODUCERS BREAKING. ALL THREE INTRODUCERS BROKE AT THE SAME SPOT. THE RIGHT WING BROKE OFF COMPLETELY, INSTEAD OF BREAKING DOWN THE CENTER OF THE INTRODUCER IN ORDER TO PEEL IT AWAY. I¿VE INCLUDED A PICTURE BELOW-THIS WAS FROM THE FIRST PATIENT, THAT OCCURRED ON (B)(6) 2023. ARE YOU ABLE TO PROVIDE THE INCIDENT DATES FOR THE THREE INSTANCES? (B)(6) 2023. ARE YOU ABLE TO PROVIDE ANY PATIENT IDENTIFIERS INCLUDING: AGE/ DATE OF BIRTH, SEX, WEIGHT, ETHNICITY, RACE, OTHER RELEVANT HISTORY INCLUDING PREEXI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079817 ↗
• MalfunctionDec 22, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED WHILE USING BD INTROSYTE-N¿ PRECISION INTRODUCER THERE WAS A HOLE IN THE SHEATH. THIS OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT "WE RECENTLY HAD AN ISSUE IN OUR NICU WITH 3 OF THE INTROSYTE-N INTRODUCERS (ALL ON THE SAME PATIENT) WHERE THE CATHETER SHEATH WAS PUNCTURED THROUGH AFTER PICC PLACEMENT ATTEMPTS. THE NNP NOTICED AFTER THE THIRD ATTEMPT, THAT THE INTRODUCER HAD A DOUBLE BEVEL NEEDLE. OUR PROVIDER TEAM FEEL QUITE CONFIDENT THAT PREVIOUSLY, OUR PICC INTRODUCERS DID NOT HAVE THIS DOUBLE BEVEL AND WERE LABELED SIMPLY "INTROSYTE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16036164 ↗
• MalfunctionApr 7, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT WHILE USING THE BD INTROSYTE-N¿, THE INTRODUCER DID NOT SPLIT PROPERLY AND WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): BD INTROSYTE-N INTRODUCER DID NOT PEEL PROPERLY UPON REMOVAL. IT EVEN BROKE TRYING TO BREAK IT, WHICH PIERCED THE KTECC IN PLACE. IN ADDITION, A SMALL PIECE OF THE INTRODUCER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046062 ↗
• MalfunctionOct 14, 2021Break; Break

  IT WAS REPORTED THAT INTRODUCER INTROSYTE-N 1.9F 1.9CM SHEATH BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NNP SLID INTRODUCER CATHETER OUT AND WENT TO PEEL IT AWAY. NNP GRABBED THE PURPLE WINGS TO SNAP AND PEEL AWAY AND ONE OF THE PURPLE WINGS COMPLETELY BROKE OFF BEFORE THE PEELING COULD BE COMPLETED.   VERBATIM: DESCRIBE THE EVENT OR PROBLEM: NEONATAL NURSE PRACTITIONER (NNP) PLACED A PICC LINE INTO PATIENT USING INTROSYTE-N INTRODUCER. AFTER VEIN WAS ACCESSED, THE NEEDLE WAS MOVED AND PICC CATHETER ADVANCED WITHOUT DIFFICULTY. NNP SLID INTRODUCER CATHETER OUT AND WENT TO PEEL IT AWAY. NNP GRABBED THE PURPLE WINGS TO SNAP AND PEEL AWAY AND ONE OF THE PURPLE WINGS COMPLETELY BROKE OFF BEFORE THE PEELING COULD BE COMPLETED. SO THERE WAS NO WAY TO CONTINUE TO REMOVE THE PEEL AWAY CATHETER. NNP HAD TO HAVE ANOTHER NNP SCRUB IN TO HOLD PICC CATHETER IN PLACE WHILE TWEEZERS WERE USED TO SLOWLY PICK OFF THE REST OF THE PEEL AWAY CATHETER. THIS WAS SUCCESSFUL AND NO HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12636537 ↗
• MalfunctionSep 2, 2021Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT INTRODUCER INTROSYTE-N 1.9F 1.9CM HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT DELIVERED MENTIONS MADE IN MEXICO BUT IN OUR SYSTEM IT SAYS MADE IN USA (ALSO ON BOXES).".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418754 ↗
• MalfunctionAug 20, 2021Break; Break

  IT WAS REPORTED THAT THE BD INTROSYTE-N¿ 26 GA (1.9F) EXPERIENCED A SHEATH THAT DID NOT SPLIT AS INTENDED, AND DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INSTALLATION OF AN EPICUTANEO-CAVAL CATHETER, THE INTRODUCER, WHEN THE CATHETER IS IN PLACE, DID NOT COME APART IN TWO BY THE WINGS AS IT IS NORMALLY DESIGNED. CLINICAL CONSEQUENCES: THE TREATMENT WAS PROLONGED BY 20 MINUTES, THE TIME TO REPAIR THE PIERCED CATHETER. CONSERVATIVE MEASURES AND ACTIONS TAKEN: INTERVENTION OF THE DOCTOR WITH FORCEPS AND SCISSORS TO REMOVE THE INTRODUCER WHICH PIERCED THE FRESHLY PLACED CATHETER AND CAUSED A LEAK ON THIS ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346389 ↗
• MalfunctionJul 22, 2021Break; Break

  IT WAS REPORTED THAT WHILE USING THE BD INTROSYTE-N¿ INTRODUCER THE SHEATH DID NOT SPLIT AS INTENDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: AFTER INSERTING THE PICC CATHETER THE INTRODUCER DID NOT OPEN TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211154 ↗
• MalfunctionJun 1, 2021Break; Leak/Splash; Device Contamination with Chemical or Other Material; Break; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT INTRODUCER INTROSYTE-N 1.9F 1.9CM WAS SPLIT, DAMAGED, AND HAD FOREIGN MATTER. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE ACTUAL EQUIPMENT WAS SOILED WITH BLOOD AND WAS DISCARDED. THE PURPLE WINGS SPLIT, BUT THE SHAFT OF THE INTRODUCER DID NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918099 ↗
• MalfunctionMay 25, 2021Break; Break

  IT WAS REPORTED THAT INTRODUCER INTROSYTE-N 1.9F 1.9CM SHEATH DID NOT SPLIT AS INTENDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 384021, BATCH NO: 0238454. IT WAS REPORTED THAT WHILE PEELING AWAY THE INTRODUCER DID NOT FULLY PEEL OFF THE LINE AT THE VERY TIP LEAVING A ROUGH EDGE.   VERBATIM: UNFORTUNATELY WE HAD ANOTHER EVENT IN THE NICU WITH THE 1.9FR 26G INTRODUCER DATE OF INCIDENT: (B)(6) 2021. ANY INJURIES AND/OR HARM? NO, PROVIDER WAS ABLE TO REMOVE FROM PATIENT AND PLACE PICC USING NEW INTRODUCER WHAT IS THE ISSUE YOU EXPERIENCED? INTRODUCER INSERTED AND LINE WAS THREADING IN AND INFANT MOVED AND INTRODUCER CAME OUT FROM THE SKIN. DECISION MADE TO PEEL AWAY THE INTRODUCER AND ATTEMPT TO CONTINUE THREADING OF PICC LINE. WHILE PEELING AWAY THE INTRODUCER DID NOT FULLY PEEL OFF THE LINE AT THE VERY TIP LEAVING A ROUGH EDGE. THE LINE CAME OUT OF THE VEIN AND PLACEMENT ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881442 ↗
• MalfunctionMay 14, 2021Break; Break

  IT WAS REPORTED THAT INTRODUCER INTROSYTE-N 1.9F 1.9CM WAS NOT WORKING PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 384021. BATCH NO: 0336137. IT WAS REPORTED INTRODUCER FAILING TO PROPERLY BREAK AWAY DURING PICC LINE INSERTION. VERBATIM: THE DATE OF THE INCIDENT WAS (B)(6) 2021. WE HAD ANOTHER EVENT IN THE NICU WITH THE 1.9FR 26G INTRODUCER FAILING TO PROPERLY BREAK AWAY DURING PICC LINE INSERTION. ANY INJURIES AND/OR HARM? NO, PROVIDER WAS ABLE TO REMOVE FROM PATIENT. WHAT IS THE ISSUE YOU EXPERIENCED? DURING PICC LINE PLACEMENT, PURPLE TAB HOLDER BROKE OFF OF NEEDLE INTROSYTE WHEN ATTEMPTING TO PEEL INTRODUCER AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829188 ↗
• MalfunctionMay 6, 2021Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT INTRODUCER INTROSYTE-N 1.9F 1.9CM SHEATH BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 384021. BATCH NO: 0183797. IT WAS REPORTED THAT THE ITEM 0183797 PEEL AWAY SHEATH BROKE AWAY AT THE TOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11788066 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED THAT WHILE USING BD INTROSYTE-N¿ CATHETER BROKE WHILE INSERTING INTO HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "PICC CATHETER BROKE INSERTION OF THE HUB, AFTER AN UNSUCCESSFUL ATTEMPT TO PASS THE PICC". WE HAVE THE PACKAGING SEGREGATED FOR ANALYSIS, THE MATERIAL WAS CONTAMINATED. ADDITIONALLY, THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: "THE ENTIRE PROCEDURE TO BE PERFORMED, SUCH AS THE PASSAGE OF THE PICC CATHETER, THE NURSE SETS UP THE TABLE AND TESTS THE DEVICE. THE CATHETER IS LUBRICATED WITH SALINE, THE INTRODUCER IS LUBRICATED AS WELL AND THE NEEDLE IS REMOVED. AT THIS MOMENT WE REALIZED THAT THE NEEDLE WAS TEARING THE INTRODUCER, SO THE BEVEL WAS BLUNT. SO IT WAS DECIDED NOT TO USE THIS DEVICE AND REQUEST ANOTHER ONE, AS IT WAS GOING TO HARM THE PUNCTURE A LOT. FOR HE WAS A CHILD WHO HAD CAPILLARY FRAGILITY AND MULTIPLE PUNCTURES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697979 ↗
• MalfunctionFeb 5, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD INTROSYTE-N¿ WAS "PLUGGED" BEFORE USE AND ONE OF THE WINGS BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "INTRODUCER PLUGGED BEFORE USE." "BREAKAGE OF ONE OF THE WINGS OF THE INTRODUCER WHEN PEELED OFF THE TWO PARTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11285968 ↗
• MalfunctionFeb 3, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE OUTER BOX INFORMATION STATED "MADE IN USA", WHILE THE BD INTROSYTE-N¿ PACKAGING STATED "MADE IN MEXICO". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I RECENTLY OBTAINED A BOX OF THIS PRODUCT 384021, LOT # 0164202. VISUALLY INSPECTING IT, THE OUTER BOX STATES "MADE IN USA". WHEN I OPENED THE BOX AND LOOKED AT AN INDIVIDUALLY PACKAGED NEEDLE, IT STATES "MADE IN MEXICO". LOT NUMBERS MATCH ON BOTH INNER AND OUTER PACKAGING."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11276858 ↗