safePICO70 956-616Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05700699566164), received between Oct 13, 2017 and Dec 23, 2025 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  RADIOMETER COMPLAINT REFERENCE: (B)(4). THE USER USED A SAFEPICO70 (LOT NUMBER: RC52) TO DRAW SAMPLE FROM A PATIENT. BLOOD SPURTED EVERYWHERE FROM THE SYRINGE AND THE USER NOTICED THE SYRINGE WAS CRACKED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23875842 ↗
• MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, THE USER USED A SAFEPICO70 (LOT NUMBER: RE54) TO DRAW SAMPLE FROM A PATIENT. THE BLOOD DRAWN WAS SUCCESSFUL AND THE AIR WAS EXPELLED NORMALLY. THE SAMPLE WAS PLACED ON THE COUNTER AND WHEN THE USER WENT TO GRAB THE SAMPLE AGAIN, THE CAP FLEW OFF THE SYRINGE SPRAYING BLOOD UP THE WALL AND ON HER CHEST AND ARM WITH FORCE. THE USER DID NOT GET THE BLOOD IN HER EYES OR MOUTH.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23847621 ↗
• MalfunctionMar 31, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE COMPLAINT, A WAREHOUSE OPERATOR FOUND THAT A SAFEPICO RETAIL BOX WAS MISSING THE INSERTS AND QUALIFIED CERTIFICATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729331 ↗
• MalfunctionJan 10, 2024Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE COMPLAINT, THE NURSES STRUGGLED WITH THE NEEDLE SAFETY ON THE SAFEPICO (LOT NUMBER: NY-50).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18482541 ↗
• MalfunctionOct 13, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE COMPLAINT, A NURSE ENCOUNTERED DIFFICULTY IN LOWERING THE NEEDLE SHIELD DEVICE ONTO THE NEEDLE OF THE SAFEPICO (LOT NUMBER: NY 54). SHE CUT HER SKIN (SUPERFICIAL WOUND) WHILE TRYING TO SET UP THE NEEDLE SHIELD DEVICE. SHE DID NOT PRICK HERSELF WITH THE NEEDLE AND THERE WAS NO EXPOSURE TO BLOOD.

  Patient problems: Abrasion

  MAUDE report 17928856 ↗
• MalfunctionNov 30, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE COMPLAINT, THE NURSE DIDN'T SUCCEED TO ACTIVATE THE NEEDLE SHIELD DEVICE ON THE SAFEPICO. AT THE END OF THE ARTERIAL SAMPLING, DROPS OF BLOOD COMING OUT OF THE NEEDLE IN A SPLASH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885882 ↗
• InjuryJun 22, 2022Protective Measures Problem; Protective Measures Problem

  ON THE (B)(6) 2022 EARLY IN THE MORNING THERE WAS AN ACCIDENT ON THE MEDICINE WARD WHERE ONE IN THE STAFF INJURED HERSELF WITH A NEEDLE FROM A SYRINGE. ARTICEL CODE SAFEPICO 956-616. LOT:NR MR-03. THE NEEDLE SHIELD WAS MOVED FORWARD BY THE NURSE TO PROTECT THE NEEDLE BUT IT WAS NOT LOCKED IN THE ENDPOSITION. WHEN THE NURSE SHOULD REMOVE THE NEEDLE INCLUDING THE SHIELD FROM THE SYRINGE THE NEEDLESHIELD MOVED BACK AGAIN AND SHE WAS INJURED BY THE NEEDLE IN HER FINGERTIP.

  Patient problems: Insufficient Information

  MAUDE report 14769668 ↗
• MalfunctionJan 28, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE COMPLAINT, A NURSE DIDN'T SUCCEED TO ACTIVATE THE NEEDLE SHIELD DEVICE ON A SAFEPICO ON THURSDAY THE 13TH (B)(6). AT THE END OF THE ARTERIAL SAMPLING, THE RETRACTION DEVICE OF THE GASOMETRY SYRINGE DID NOT WORK, FORCING THE CUSTOMER TO LEAVE THE NEEDLE UNSAFE FOR THE TIME TO PROCEED WITH THE COMPRESSION OF THE PUNCTURE POINT AND THEN TO MANIPULATE THE SYRINGE TO MANUALLY WITHDRAW THE COLLECTION SYSTEM. THE EVENT OCCURRED SEVERAL TIMES IN THE SAME DAY (3 TIMES) BUT HAD ALREADY OCCURRED THE PREVIOUS DAYS (SAME BATCH).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384165 ↗
• InjuryDec 6, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE COMPLAINT, AN EMPLOYEE WAS DOING ARTERIAL BLOOD GAS SAMPLING AND WHILE ATTEMPTING TO ACTIVATE THE SAFETY MECHANISM DEVICE THE SAFETY COVER GOT STUCK SO THE EMPLOYEE REACHED OVER WITH THE OTHER HAND TO BRING THE COVER OVER THE NEEDLE AND POKED SELF WITH THE NEEDLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12932858 ↗
• MalfunctionJul 13, 2021Mechanical Problem; Use of Device Problem; Fail-Safe Problem; Mechanical Problem; Use of Device Problem; Fail-Safe Problem

  ACCORDING TO THE COMPLAINT THE NURSE DIDN'T SUCCEED TO ACTIVATE THE NEEDLE SHIELD DEVICE ON A SAFEPICO REF (B)(4) LOT NUMBER HY-53 ON TUESDAY THE 27 APRIL. NO CONSEQUENCES ON A PATIENT BUT THE NURSE EXPLAIN THAT THERE IS A HIGH RISK OF BLOOD EXPOSURE BECAUSE OF THIS.NO PICTURES OR DEFECTIVE PART AVAILABLE.NO REPORTS OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159012 ↗
• MalfunctionJun 25, 2021Mechanical Problem; Protective Measures Problem; Mechanical Problem; Protective Measures Problem

  ACCORDING TO THE COMPLAINT THE NURSE DIDN'T SUCCEED TO ACTIVATE THE NEEDLE SHIELD DEVICE ON A SAFEPICO REF 956-616 LOT NUMBER KQ-03 ON WEDNESDAY THE 28TH APRIL. IT HAPPENED AGAIN ON LOT NUMBER HY-53 TUESDAY THE 27 APRIL. NO CONSEQUENCES ON A PATIENT BUT THE NURSE EXPLAINED THAT THERE IS A HIGH RISK OF BLOOD EXPOSURE BECAUSE OF THIS. NO REPORTS OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12065096 ↗
• MalfunctionJan 13, 2021Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTS THAT NURSES HAVE HAD A LOT OF DIFFICULTIES TO ACTIVATE THE NEEDLE SHIELD DEVICE SEVERAL TIMES. THE CUSTOMER FAILED TO ACTIVATE THE NEEDLE SHIELD DEVICE. THEY HAVE NOT BEEN ABLE TO MOVE THE SECURITY DOWN. THEY SAID THAT THE PLASTIC WAS TOO HARD. THERE ARE NO REPORTS OF SERIOUS INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11162769 ↗
• MalfunctionOct 9, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE COMPLAINT, A CUSTOMER OPENED STERILE PACKAGING OF A SAFEPICO SAMPLER TO FIND WHAT LOOKS LIKE A HAIR INSIDE. THERE ARE NO REPORTS OF SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10654346 ↗
• MalfunctionMar 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE COMPLAINT RECEIVED, BLOOD PROJECTED FROM THE VTC WHEN PURGING AIR AFTER BLOOD SAMPLING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439638 ↗
• InjuryAug 14, 2018Break; Fracture; Break; Fracture

  AFTER TAKING THE SAMPLE, THE USER TRIED TO EXPEL THE AIR OUT OF THE SYRINGE AND IT SQUIRTED BLOOD INTO HIS MOUTH AND ON HIS FACE. PPE (FACE SHIELD) WAS NOT USED. CUSTOMER STATED THAT THE SIDE OF THE BARREL WAS POSSIBLY CRACKED. ACCORDING TO THE CUSTOMER THERE WAS NO HARM TO THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7782430 ↗
• MalfunctionJun 8, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ACCORDING TO THE COMPLAINT, ON (B)(6) 2017, WHEN PURGING THE SYRINGE OF A SAFEPICO, BLOOD SPRAYED FROM THE SAMPLER AND GOT IN CONTACT WITH THE USERS GLOVES. THE CUSTOMER REPORTED THAT THERE IS A CRACK ON THE BODY OF THE SYRINGE HALF A CENTIMETER THAT ALLOWED THE FLOW OF BLOOD. THE SYRINGE WAS DISCARDED.

  Patient problems: No Patient Involvement

  MAUDE report 7581609 ↗
• MalfunctionMay 28, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO THE COMPLAINT, BLOOD SPRAYED OUT FROM THE SYRINGE. THE BLOOD HIT THE USER. HOWEVER, THE BLOOD HIT THE SHIRT IN THE AREA OF THE CHEST REGION. THE CUSTOMER REPORTED THAT THERE IS A CRACK ON THE BODY OF THE SYRINGE ALLOWING FLOW OF BLOOD.

  Patient problems: No Patient Involvement

  MAUDE report 7547375 ↗
• MalfunctionMay 9, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO THE COMPLAINT, BLOOD SPRAYED UNCONTROLLABLY OUT FROM THE SYRINGE. THE USER (A NURSE) WAS NOT IN CONTACT WITH BLOOD.

  Patient problems: No Patient Involvement

  MAUDE report 7497783 ↗
• MalfunctionJan 11, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE COMPLAINT BLOOD LEAKED FROM THE SAMPLER DUE TO A CRACK IN THE SAMPLER. THE OPERATOR USED GLOVES, BUT BLOOD SPLASHED TO THE SKIN. THE SKIN WAS CLEANED IMMEDIATELY. ACCORDING TO THE CUSTOMER, THE BLOOD SAMPLE HAD NO INFECTIOUS DISEASE.

  Patient problems: No Patient Involvement

  MAUDE report 7181521 ↗
• MalfunctionOct 13, 2017Occlusion Within Device; Device Operates Differently Than Expected

  RADIOMETER SAFE PICO ARTERIAL BLOOD GAS SAMPLING KIT FOUND TO CLOT AFTER FLASH OF BLOOD. PATIENT SAMPLE WAS OBTAINED AFTER FOURTH ATTEMPT. WHEN EVALUATING THE CAUSE, THE RESPIRATORY THERAPIST FOUND THAT ON THE PACKAGING, TWO DIFFERENT FONT SIZES AND TYPES WERE NOTED; HOWEVER, BOTH HAD THE SAME KIT NUMBER, LOT NUMBER AND EXPIRATION DATE. THE RT REPORTED THAT THE KIT WITH SMALLER FONT WOULD CLOT UPON FLASH AND SMALL SAMPLE OF BLOOD INTO THE SYRINGE. UPON REMOVAL FROM THE PATIENT, THE PLUNGER WAS MOVED BACK AND FORTH WITH CLOTS EXPELLED FROM THE SYRINGE. ORIGINALLY, THE KIT WITH SMALLER FONT WAS THE ITEM FOUND TO CLOT X 3 DIFFERENT SYRINGES AND THE KIT WITH THE LARGER FONT WORKED. HOWEVER, UPON DISCUSSION WITH RT STAFF, THE OPPOSITE HAPPENED TO A DIFFERENT RT (PATIENT UNKNOWN). GIVEN THE CONCERN, ALL ABG KITS WITH THAT LOT NUMBER AND EXPIRATION DATE WERE PULLED FROM SERVICE AND REPLACED BY THE RADIOMETER REP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6947400 ↗