Closed Wound Suction 0071370Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741049651), received between Nov 7, 2021 and Nov 22, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2021Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DRAINAGE EVACUATOR BROKE RIGHT AT THE JOINT BETWEEN THE TRANSLUCENT AND WHITE SOLID PART. IT WAS MENTIONED THAT THIS WAS THE SECOND DRAIN THAT BROKE. PER FOLLOW-UP INFORMATION VIA EMAIL ON 01NOV2021, IT WAS REPORTED THAT THE PRODUCT WAS USED ON THE PATIENT BUT THERE WAS NO PATIENT INJURY REPORTED. IT WAS ALSO MENTIONED THAT THE REPRESENTATIVE PICKED UP ONE BROKEN UNIT AND THAT WAS NOT THE DEVICE THAT BROKE OFF IN THE PATIENT. IT WAS FURTHER REPORTED STATED THAT DRAIN WAS PLACED THROUGH THE ABDOMINAL WALL INTRA-OPERATIVELY. IT WAS ORDERED TO BE REMOVED POST-OPERATIVELY ON DAY 6. WHEN NURSE PULLED ON THE DRAIN, IT CAME OUT EASILY, BUT DID NOT HAVE ANY PORTION OF THE WHITE PART OF DRAIN ATTACHED. HENCE, THE PATIENT REQUIRED A REPEAT LAPAROTOMY OPERATION TO RETRIEVE THE WHITE PORTION OF THE DRAIN WHICH PUT THE PATIENT AT A RISK FOR POORER WOUND HEALING AND DELAYED RECOVERY FROM THE ORIGINAL OPERATION. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 01NOV2022, STATED THAT THE PATIENT HAD AN ABDOMINAL OPERATION ON (B)(6) 2021 WHICH REQUIRED THE POST-OPERATION USE OF TWO DRAINAGE BAGS MANUFACTURED BY BECTON DICKINSON. DURING THE POST-OPERATION RECOVERY TIME IN HO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851981 ↗
• InjuryNov 7, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DRAINAGE EVACUATOR BROKE RIGHT AT THE JOINT BETWEEN THE TRANSLUCENT AND WHITE SOLID PART. THIS WAS THE SECOND DRAIN THAT WAS BROKEN. PER FOLLOW-UP INFORMATION VIA EMAIL ON 01NOV2021, THE PHOTO WAS ATTACHED. THE LOT NUMBER WAS UNKNOWN. THE PRODUCT WAS USED ON THE PATIENT, THERE WAS NO PATIENT INJURY REPORTED. THE REPRESENTATIVE PICKED UP ONE BROKEN UNIT AND THAT WAS NOT BROKEN OFF IN THE PATIENT. PER FOLLOW-UP INFORMATION VIA EMAIL ON 01NOV2021, IT WAS STATED THAT THE DRAIN WAS PLACED THROUGH THE ABDOMINAL WALL INTRAOPERATIVELY. IT WAS ORDERED TO BE REMOVED ON POST-OPERATIVE DAY 6. WHEN THE NURSE PULLED ON THE DRAIN, IT CAME OUT EASILY, BUT DID NOT HAVE ANY PORTION OF THE WHITE PART OF THE DRAIN ATTACHED. ALSO, STATED THAT THE PATIENT REQUIRED A REPEAT OPERATION (LAPAROTOMY) TO RETRIEVE THE WHITE PORTION OF THE DRAIN. THIS PUTS THE PATIENT AT RISK FOR POORER WOUND HEALING AS A RESULT AND DELAYED RECOVERY FROM THE ORIGINAL OPERATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 12760496 ↗