MediChoiceRecalls & reported problems across all models

We found 6 models of MediChoice by Owens & Minor Distribution, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2017 and Nov 12, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

MediChoice recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 6, 2023Open, Classified

   Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.

   Z-0513-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported MediChoice problems

MediChoice models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MediChoice SWF071

  Dressing, wound, drug
  1 recall0 reports
• MediChoice RSC14

  CATHETER AND TIP, SUCTION
  2 reports
• Medichoice ORT04B

  Drape, surgical
  1 report
• Medichoice HTB060

  Pack, hot or cold, water circulating
  1 report
• MediChoice BTD002

  System, blood collection, vacuum-assisted, manual
  1 report
• MediChoice 50010

  Tubes, vials, systems, serum separators, blood collection
  1 report

Recent MediChoice adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2024

  PATIENT WITH SEPTIC FEVER, COOLING BLANKET ORDERED. WHEN ATTACHING THE COOLING BLANKET TO THE AIR TUBING, THE BLANKET WOULD NOT HOLD AIR. TROUBLESHOOTING DID NOT CHANGE OUTCOME. A NEW WARMING BLANKET WAS OBTAINED AND FUNCTIONED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662034 ↗
• MalfunctionJun 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  BLOOD TRANSFER DEVICE IS FILLING WITH BLOOD BECAUSE THE RUBBER STOPPER IS NOT WORKING PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 19465085 ↗
• OtherNov 24, 2023

  HAD 3 KNOWN INSTANCES WHERE THE BLACK NEEDLE PIECE IN THE BLOOD TRANSFER DEVICE BECAME DETACHED FROM THE REST OF THE BLOOD TRANSFER DEVICE. ONE WAS SUCKED INTO A BLOOD CULTURE BOTTLE. THE OTHER TWO WERE ABLE TO BE REMOVED FROM THE BOTTLES. HOWEVER, THESE PUT PATIENTS AND PERSONNEL AT RISK TO INFECTIOUS MATERIAL, BLOOD BORNE PATHOGENS AND UNNECESSARY TREATMENT. ONE OF THE PHLEBOTOMISTS WAS SPRAYED BY BLOOD DUE TO THE FAILURE. REFERENCE REPORT #MW5148488, #MW5148489.

  Patient problems: Exposure to Body Fluids

  MAUDE report 18208902 ↗
• InjuryJul 1, 2022Difficult to Remove; Difficult to Remove

  PATIENT NUMBER 1: PER CUSTOMER, THE ENDOTRACHEAL TUBE SUCTION CATHETER GETS STUCK IN THE ENDOTRACHEAL TUBE. THE CATHETER IS STICKY. THE COMPLAINT SITE INDICATES THEY WERE UNABLE TO VENTILATE PATIENT DURING AORTIC DISSECTION PROCEDURE RESULTING IN PATIENT OXYGEN DESATURATION. THE PATIENT HAD A CARDIAC ARREST REQUIRING CPR.

  Patient problems: Cardiac Arrest

  MAUDE report 14892638 ↗
• InjuryJul 1, 2022Difficult to Remove; Difficult to Remove

  PATIENT NUMBER 2: IT WAS REPORTED THAT SUCTION CATHETER WAS STUCK. WHEN THE PACU RN TRIED TO PULL IT OUT, IT SNAPPED IN HALF. THE PATIENT WAS EXTUBATED AND PLACED ON BIPAP MACHINE UNTIL ABLE TO MAINTAIN AN AIRWAY ON THEIR OWN. THE PATIENT STABILIZED AFTER EVENT WITHOUT FURTHER TREATMENT.

  Patient problems: Unintended Extubation

  MAUDE report 14889496 ↗
• MalfunctionDec 1, 2017Device Contamination with Chemical or Other Material

  A HAIR WAS FOUND INSIDE THE STERILE PACKAGE OF A DISPOSABLE OR TOWEL. THIS WAS DISCOVERED PRIOR TO THE TOWELS BEING INTRODUCED TO THE STERILE FIELD. THE CONTAMINATED PACKAGE WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO PATIENT CONTAMINATION. PER SITE REPORTER: RESPONSE FROM THE MANUFACTURER IS STILL PENDING. WE WILL RETURN PACK FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7074294 ↗

Other Owens & Minor Distribution, Inc. products

• Halyard9 models · 4 reports · 2 recalls