BD Hypoint™ 300263Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00382903002634), received between Jan 8, 2018 and May 19, 2023 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD HYPOINT¿ NEEDLE THE NEEDLE AND SYRINGE WERE DIFFICULT TO CONNECT AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE INFORM YOU THAT WE HAVE RECEIVED A NEW COMPLAINT FOR A NEEDLE QUALITY PROBLEM (¿PATIENT REPORTED DIFFICULTIES TO OPEN THE BLISTER OF THE NEEDLE. HE ALSO INDICATED THAT HE HAD DIFFICULTIES WHEN SCREWING ON THE NEEDLE, THE LIQUID SPILLED OUT.¿). BATCH OF 22G NEEDLES (HYPOINT NDL 22GA1-1/2IN TW) IMPACTED: 210200238 (SUPPLIER BATCH 0104324); THIS IS THE 3RD COMPLAINT AFFECTING THIS BATCH OF NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16967678 ↗
• MalfunctionMar 22, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD HYPOINT¿ NEEDLE AND SYRINGE SEPARATED WHILE INJECTING DILUENT INTO THE VIAL AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "HE TRIED TO INJECT THE DILUENT INTO THE VIAL AND THE NEEDLE ¿SLIPPED/POPPED¿ OUT FROM THE SYRINGE AND CAUSED ALL THE DILUENT TO SPILL OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595514 ↗
• MalfunctionSep 23, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD HYPOINT¿ NEEDLE WAS BLOCKED AND SOLUTION COULDN'T BE DRAWN INTO THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "REPORTER STATED THAT THEY WERE NOT ABLE TO DRAW UP THE SOLUTION INTO THE SYRINGE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15474318 ↗
• MalfunctionJul 29, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 1 BD HYPOINT¿ NEEDLE HAD NEEDLE BLOCKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH : THE USER STATED THAT THE COMPLETE EXTRACTION OF THE SOLUTION FROM THE VIAL WAS NOT POSSIBLE. THE CLAIM SAMPLE IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136579 ↗
• MalfunctionJul 14, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD HYPOINT¿ NEEDLE WAS BLOCKED OR EXTRUSION IS ONLY PARTIALLY POSSIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " WE INFORM YOU OF A NEEDLE QUALITY PROBLEM (¿REPORTER STATED THAT SOMETIMES -SYRINGE IS BLOCKED -OR EXTRUSION IS ONLY PARTIALLY (30% OF SUSPENSION) POSSIBLE¿).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15018674 ↗
• MalfunctionApr 7, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD HYPOINT¿ NEEDLE SEPARATED FROM THE SYRINGE DURING USE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE NEEDLE ESCAPED DURING PREPARATION, CAUSING A LEAK"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14045000 ↗
• MalfunctionJan 11, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD HYPOINT¿ NEEDLE WAS BLOCKED AND COULDN'T EXPEL SOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EXTRACTION OF THE SOLUTION WAS NOT POSSIBLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13224336 ↗
• MalfunctionOct 9, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED HYPOINT NDL22GA1-1/2IN TW HAD AN ISSUE WITH NEEDLE BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE PATIENT FAILED TO INSERT ALL THE LIQUID FROM THE SYRINGE INTO THE BOTTLE¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602260 ↗
• MalfunctionAug 5, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT HYPOINT NDL22GA1-1/2IN TW NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE INFORM YOU THAT WE HAVE RECEIVED A NEW COMPLAINT FOR A NEEDLE QUALITY PROBLEM (¿WHEN HE WENT TO PREPARE THE MEDICATION FOR USE, HE REPORTED THAT THE SYRINGE DID NOT PULL OR INJECT THE LIQUID TO MAKE THE MIXTURE¿).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284493 ↗
• MalfunctionApr 21, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT HYPOINT NDL22GA1-1/2IN TW LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PERFORMING THE DILUTION OF THE PRODUCT, NOTICED THAT THE NEEDLE THREAD WAS LOOSE, AS THERE WAS LEAKAGE AND CONSEQUENT LOSS OF MEDICAMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704407 ↗
• MalfunctionApr 1, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRODUCT LEAKED FROM THE HYPOINT NDL22GA1-1/2IN TW SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE REPORTER CLAIMS THAT HE/SHE COULD NOT REMOVE THE THICK NEEDLE FROM THE SYRINGE AND THE PRODUCT LEAKED OUT FROM THE SYRINGE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603284 ↗
• MalfunctionFeb 17, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT HYPOINT NDL22GA1-1/2IN TW LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE INFORM YOU THAT WE HAVE RECEIVED A NEW COMPLAINT FOR A NEEDLE QUALITY ISSUE (¿THE PHARMACIST INFORMED THAT HE HAD ALREADY BEEN IN CONTACT BECAUSE THE CLIENT WENT TO MAKE THE NEEDLE BIGGER AND THERE WAS A LEAK OF THE PRODUCT¿). UPDATE : BIGGER NEEDLE (NEEDLE 22G) USED FOR THE PREPARATION OF THE RECONSTITUTED SOLUTION ¿ LITTLE NEEDLE (NEEDLE 30G) USED ONLY FOR THE INJECTION OF THE RECONSTITUTED SOLUTION.

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

  MAUDE report 11340777 ↗
• MalfunctionJan 26, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF HYPOINT NDL22GA1-1/2IN TW LEAKED AT THE CONNECTION SITE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "WE INFORM YOU THAT WE RECEIVED A NEW COMPLAINT FOR A NEEDLE QUALITY ISSUE (¿WHEN HE WAS INJECTING THE LIQUID INSIDE THE BOTTLE, LEAKED MEDICATION BY THE CONNECTION INSTEAD THE TIP OF THE NEEDLE¿). NEEDLES 22G (HYPOINT NDL 22GA1-1/2IN TW) IMPACTED: 19090090 (SUPPLIER LOT 9155552) ET 20020027, (SUPPLIER LOT 9287090. THE SAMPLE FOR THIS COMPLAINT IS NOT AVAILABLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11234275 ↗
• MalfunctionOct 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT HYPOINT NDL22GA1-1/2IN TW NEEDLE WAS LOOSE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RAPPORTEUR REPORTED THAT DURING THE PREPARATION OF THE PRODUCT, WHEN INJECTING THE DILUENT IN THE BOTTLE, THE NEEDLE CAME LOOSE AND PART OF THE DILUENT WAS WASTED. THE NEEDLE WAS WELL FITTED BY HER, AS SHE IS ALREADY USED TO THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 10714631 ↗
• MalfunctionJun 18, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT HYPOINT NDL22GA1-1/2IN TW LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE INFORM YOU THAT WE HAVE RECEIVED A NEW COMPLAINT FOR A NEEDLE QUALITY ISSUE ¿PATIENT STATED AFTER RECONSTITUTION DURING DREW THE SOLUTION INTO SYRINGE, THE SOLUTION WAS LEAKING¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10172165 ↗
• MalfunctionMay 1, 2020Break; Break

  IT WAS REPORTED THAT HYPOINT NDL22GA1-1/2IN TW HAD A BROKEN NEEDLE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE WAS FOUND BROKEN BEFORE USING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10018120 ↗
• MalfunctionMar 13, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE HYPOINT NDL22GA1-1/2IN TW WAS BLOCKED AND WOULDN'T WITHDRAW THE CONTENTS OF THE VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REGULAR PATIENT CAN'T WITHDRAW THE CONTENT FROM THE VIAL."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9831801 ↗
• MalfunctionJul 1, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE HYPOINT NDL22GA1-1/2IN TW EXPERIENCED PRODUCT DAMAGE WITH THE DEVICE STILL OPERABLE. IT IS UNKNOWN WHETHER THE ITEM DEFECT WAS NOTED PRIOR TO, DURING, OR AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE INFORM YOU THAT WE RECEIVED A NEW COMPLAINT FOR A NEEDLE QUALITY ISSUE. NEEDLE BATCH IMPACTED 22G (HYPOINT NDL 22GA1-1/2IN TW) 18050014 (SUPPLIER BATCH 8038451).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8748608 ↗
• MalfunctionMay 16, 2019Failure to Deliver

  IT WAS REPORTED THAT MEDICATION IS NOT INJECTED DUE TO DIFFICULT PLUNGER WITH A BD HYPOINT¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE PREPARATION OF THE SYRINGE BEFORE THE INJECTION, THE SOLUTION DID NOT COMES OUT WHEN HE PUSHED PLUNGER.

  Patient problems: Missed Dose

  MAUDE report 8617838 ↗
• MalfunctionFeb 18, 2019Mechanical Problem

  IT WAS REPORTED THAT THE BD HYPOINT NEEDLE EXPERIENCED DIFFICULT PLUNGER MOVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8348343 ↗
• MalfunctionJan 8, 2018Fluid/Blood Leak

  IT WAS REPORTED DURING USE OF THE BD HYPOINT NEEDLE THE PRODUCT IS LEAKING AT THE LUERLOCK LOCATION DURING PREPARATION, WHEN TAKING THE LIQUID FROM THE VIAL TO THE SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7173124 ↗