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PILLING IPN006422Recalls & reported problems

Teleflex Incorporated · Class 1

All models of PILLING (28)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 24026704204810), received between Jan 9, 2023 and Jan 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Clean Adequately” (1 report).

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 16, 2026.

Most reported problems

Device problems

  • Failure to Clean Adequately1
  • Precipitate in Device or Device Ingredient1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 9, 2023Precipitate in Device or Device Ingredient; Failure to Clean Adequately; Precipitate in Device or Device Ingredient; Failure to Clean Adequately

    RECEIVED VIA MEDWATCH# MW5113646. REPORTED ISSUE: DECONTAMINATION PROCESS IN STERILE PROCESSING, IT WAS NOTED THAT AFTER CLEANING AND DISINFECTION BLOOD CONTINUED COMING OUT OF THE DISTAL TIP WHEN AN EMPLOYEE FLUSHED IT WITH ALCOHOL ON THE CLEAN SIDE OF SPD. THE RETRACTOR WAS RETURNED TO THE DIRTY SIDE OF SPD TO UNDERGO CLEANING AND DISINFECTION (FLUSH AND SOAK WITH ENZYMATIC CLEANER, FORCED AIR, REPEAT FLUSHING, 10-MINUTE ULTRASONIC CYCLE FOLLOWED BY 30 MIN WASH CYCLE) AFTER TWO CYCLES OF THIS DECONTAMINATION PROCESS, WHEN FLUSHED WITH ALCOHOL, BLOOD WAS STILL COMING FROM THE DISTAL THE RETRACTOR. THE RETRACTOR WAS AGAIN SENT BACK THROUGH THE DECONTAMINATION PROCESS FOR A THIRD TIME IN WHICH DID YIELD NO MORE BLOOD WHEN FLUSHED WITH ALCOHOL. AT THIS POINT OUR SPD MANAGER DECIDED TO LOOK AT IT WITH OUR BAROSCOPE JUST TO BE SAFE. IMMEDIATELY HE SAW BIO BURDEN AT THE DISTAL TIP. HE WENT AND PUSHED THE CAMERA ALL THE WAY THROUGH AND SAW MORE BIO BURDEN. HE REPEATED ALL THE STEPS AGAIN IN DECON. AFTER COMING OUT OF THE WASH, HE USED THE BAROSCOPE AGAIN AND SAW THAT BIO BURDEN WAS STILL PRESENT AT THE DISTAL TIP, BUT THE BIO BURDEN FURTHER BACK WAS GONE. I HAD DECIDED AT THIS POINT TO L

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16124351 ↗

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Sources and updates

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