safePICO 956-623Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05700699566232), received between May 23, 2019 and Apr 21, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Crack; Leak/Splash

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT, THE HOSPITAL REPORTED THAT ON (B)(6) 2026 DURING A BLOOD GAS SAMPLE COLLECTION AS PART OF A ROUTINE CHECK-UP, THE SAMPLING SETUP WITH A RADIOMETER ARTERIAL BLOOD SAMPLER SAFEPICO (LOT NUMBER UNKNOWN) HAD BEEN PREPARED IN ADVANCE BY THE NIGHT NURSE. DURING THE PROCEDURE, BLOOD WAS OBSERVED ON THE NURSE'S FINGER, THOUGH ITS SOURCE COULD NOT BE IDENTIFIED. DURING THE PROCESS OF PURGING THE BLOOD GAS SYRINGE USING THE SPECIFIC STOPPER, A SPLASH OF BLOOD OCCURRED DUE TO A CRACK IN THE SYRINGE. NO BLOOD REACHED THE FACE OF THE NURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24937364 ↗
• InjuryJul 12, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  ON (B)(6) 2023, THE NEEDLE GUARD WAS BLOCKED ON A SAFEPICO 956-623 (LOT: NL51) WHEN THE USER (FEMALE, AGE 24) WAS HANDLING IT. THE USER TOOK THE BLOOD SAMPLE AND AFTERWARDS PRICKED HER FINGER WITH THE USED NEEDLE. THE USER WAS CHECKED AND CONTINUED WORKING AFTER THE INCIDENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17304838 ↗
• InjuryNov 22, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE COMPLAINT, THE NURSE WAS NOT ABLE TO ACTIVATE THE NEEDLE SHIELD DEVICE ON THE SAFEPICO AND WAS PRICKED BY THE NEEDLE AT THE END OF THE ARTERIAL SAMPLING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15842065 ↗
• InjuryOct 22, 2019Detachment of Device or Device Component; Fail-Safe Did Not Operate; Detachment of Device or Device Component; Fail-Safe Did Not Operate

  A RESPIRATORY THERAPIST HAD A NEEDLE STICK FROM SAFEPICO BLOOD SAMPLER. AFTER NORMAL BLOOD SAMPLING PROCEDURE THE THERAPIST COULD NOT ACTIVATE THE SAFETY SHIELD OF THE SAMPLER, WHICH ULTIMATELY LED TO A FINGER STICK. THE THERAPIST STATED THAT SHE HAS EXPERIENCED SEVERAL BLOOD SAMPLERS WHERE THIS SAFETY MECHANISMS FAILS TO WORK. THE THERAPIST WAS FOLLOWING TESTED IN THE EMERGENCY DEPARTMENT AFTER THE NEEDLE STICK.

  Patient problems: Needle Stick/Puncture; No Consequences Or Impact To Patient

  MAUDE report 9217757 ↗
• MalfunctionMay 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHARMACY OF TOULON HOSPITAL COMPLAINED THAT IT WAS NOT POSSIBLE TO ACTIVATE THE NSD ON THREE CONSECUTIVE SYRINGES TAKEN FROM BATCH HD-53. THE USER WAS NOT ABLE TO ACTIVATE THE NSD WITH ONE HAND. IT FELT LIKE AS THE NEEDLE SHIELD WAS SEALED TO THE SYRINGE. THEY HAD TO USE BOTH HANDS TO MAKE IT MOVE. NO PERSONS WERE EXPOSED TO BLOOD AND NO IMPACT PATIENT MANAGEMENT. THE PERSON WHO DREW THE SAMPLE HAS BEEN CORRECTLY TRAINED TO USE OUR SAMPLER. ACCORDING TO INFORMATION FROM THE CUSTOMER THE AFFECTED SYRINGES WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8635949 ↗