safePICO70 956-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05700699566102), received between Mar 21, 2018 and May 2, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Labelling, Instructions for Use or Training Problem; Manufacturing, Packaging or Shipping Problem; Labelling, Instructions for Use or Training Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE COMPLAINT, A WAREHOUSE OPERATOR FOUND THAT A SAFEPICO RETAIL BOX WAS MISSING THE INSERTS, QUALIFIED CERTIFICATE AND 2 SAMPLERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949609 ↗
• MalfunctionJan 27, 2021Crack; Leak/Splash; Crack; Leak/Splash

  THE (B)(6) 2020, THE NURSE HAS BEEN EXPOSED TO BLOOD BECAUSE OF A SAFEPICO SYRINGE DEFAULT. JUST AFTER DRAWING AN ARTERIAL SAMPLE, SHE TRIED TO PURGE IT AND BLOOD LEAKED BY THE PISTON WHICH CAUSED A BLOOD SPILLAGE. IT WAS REPORTED THAT THE BLOOD SPRAYED ON THE CLOTHES OF THE NURSE. NO BLOOD CAME INTO CONTACT WITH THE SKIN OR MUCOUS MEMBRANES OF THE NURSE, SHE WAS WEARING A BLOUSE AND PROTECTIVE GLASSES. THE CUSTOMER REPORTED THIS INCIDENT TO THE LOCAL AUTHORITIES (ANSM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11235854 ↗
• MalfunctionJun 12, 2019Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  DURING AN INTERNAL INSPECTION, A HAIR WAS FOUND INSIDE THE PACKAGE ACROSS THE SEALING AREA.

  Patient problems: No Patient Involvement

  MAUDE report 8691078 ↗
• MalfunctionMay 31, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO THE COMPLAINT, BLOOD SPRAYED FROM THE TOP OF THE VENTED TIP CAP OF THE SYRINGE. HOWEVER, THE OPERATOR WAS NOT IN CONTACT WITH BLOOD.

  Patient problems: No Patient Involvement

  MAUDE report 7555873 ↗
• MalfunctionMay 31, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO THE COMPLAINT, BLOOD PROJECTED OUT FROM THE SYRINGE DUE TO A CRACK ON THE BODY OF THE SYRINGE. THE USER WAS NOT IN CONTACT WITH BLOOD.

  Patient problems: No Patient Involvement

  MAUDE report 7555769 ↗
• MalfunctionMay 17, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO THE COMPLAINT, BLOOD SPRAYED OUT FROM THE SYRINGE AND HIT THE USER. THE CUSTOMER REPORTED THAT THERE IS A CRACK ON THE BODY OF THE SYRINGE ALLOWING FLOW OF BLOOD. THE SYRINGE WAS KEPT, HOWEVER RADIOMETER HAS NOT RECEIVED IT FOR FURTHER INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 7521853 ↗
• MalfunctionApr 11, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE CUSTOMER EXPERIENCED BLOOD SPRAYING FROM A CRACK IN THE CYLINDER OF THE SAFEPICO BLOOD SAMPLER. THE PERSON WHO HANDLED THE SAMPLER, WAS WEARING GLOVES, PROTECTIVE SUIT AND A FACE MASK, THAT PROTECTED HER FROM THE BLOOD EXPELLED FROM THE SYRINGE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7421235 ↗
• InjuryMar 23, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO THE COMPLAINT RECEIVED, THE CUSTOMER REPORTED THAT BLOOD LEAKED OUT OF A CRACK ON THE SIDE OF THE SYRINGE WHEN THE BLOOD SAMPLE WAS VENTILATED. THE USER WAS HIT IN THE EYE WITH (B)(6) INFECTED BLOOD.

  Patient problems: No Patient Involvement

  MAUDE report 7364955 ↗
• MalfunctionMar 21, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO THE COMPLAINT ON (B)(6) 2018, A CUSTOMER EXPERIENCED A BLOOD LEAKAGE FROM A CRACK IN THE SYRINGE WHEN THEY TRIED TO REMOVE AIR FROM THE SAMPLE. NOBODY CAME INTO CONTACT WITH BLOOD. ACCORDING TO THE COMPLAINT ON (B)(6) 2018, A CUSTOMER EXPERIENCED A BLOOD LEAKAGE FROM A CRACK IN THE SYRINGE WHEN THEY TRIED TO REMOVE AIR FROM THE SAMPLE. NOBODY CAME INTO CONTACT WITH BLOOD.

  Patient problems: No Patient Involvement

  MAUDE report 7356609 ↗