PVC Drain with Trocar 0080710Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741050121), received between Jul 2, 2018 and Jun 30, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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 16, 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.

• InjuryJun 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT WAS GETTING READY TO BE DISCHARGED. THE HEMOVAC WOUND DRAIN THAT WAS PLACED DURING THE SPINAL FUSIONS NEEDED TO BE PULLED. THE RESIDENT ON CALL CAME TO PULL THE DRAIN AND THE DRAIN BROKE WHILE IT WAS BEING REMOVED. THE TIP REMAINED IN THE PATIENT. THE PATIENT THEN WENT TO THE OR FOR AN I & D. THE INCIDENT EXTENDED THE PATIENTS LENGTH OF STAY BY 1 -2 DAYS. THE HEALTHCARE FACILITY ADDITIONALLY INDICATED THAT THE ISSUE OCCURRED ON (B)(6) 2025 AND NOTED THE DEPARTMENT IN QUESTION AS CHILD HEALTH. THIS NOTICE SERVES TO REQUEST SUBMISSION OF ANY INVESTIGATIVE ACTIONS UNDERTAKEN (ALONG WITH ASSOCIATED FINDINGS) AND CORRECTIVE MEASURES IMPLEMENTED IN RESPECT OF THIS REPORT AS SOON AS POSSIBLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22360144 ↗
• MalfunctionAug 23, 2022Fitting Problem; Device Handling Problem; Fitting Problem; Device Handling Problem

  IT WAS REPORTED THAT THE WOUND DRAINS MATERIAL - 0080720, MATERIAL - 0080710 AND MATERIAL - 0070310 DID NOT FIT WITH THE SILICONE EVACUATOR BULBS (MATERIAL - 0070740). CUSTOMER STATED THAT THE FIRST TWO DRAINS (MATERIAL - 0080720, MATERIAL - 0080710) DID NOT COME WITH AN ADAPTOR. THE LAST ONE, MATERIAL - 0070310 HAD AN ADAPTOR BUT DID NOT FIT WITH THE EVACUATOR BULB. PER FOLLOW-UP VIA EMAIL ON 02AUG2022, BD REPRESENTATIVE SUGGESTED CUSTOMER THAT MATERIAL - 0080710 AND MATERIAL - 0080720 WERE PVC DRAINS THAT WERE NOT CONNECTING. AND STATED THAT THEY WERE NOT LIKE MATERIALS, AS A PVC DRAIN CANNOT CONNECT TO THE SILICONE BULB. THE REPRESENTATIVE ADVISED THAT THE SILICONE DRAIN MATERIAL - 0070310 SHOULD CONNECT WITH SILICONE EVACUATOR MATERIAL - 0070740 SINCE THEY BOTH WERE SILICONE MATERIALS, AND THE CONNECTORS WERE WITHIN THE SILICONE DRAIN PACKAGING. PER ADDITIONAL INFORMATION RECEIVED ON 15AUG2022, CUSTOMER REPORTED THAT THEY WERE STILL HAVING ISSUES WITH DRAINS. THE BULBS THEY ORDERED WERE NOT THE GRENADE TYPE. PER ADDITIONAL INFORMATION RECEIVED ON 16AUG2022, CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH SOME HEMOVAC DRAINS (MATERIAL - 0043650). THEY USED JACKSON-PRATT (J/P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274639 ↗
• MalfunctionJun 17, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE WOUND DRAIN WAS PULLING OUT OF THE 100CC SILICONE EVACUATOR CONSISTENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14732101 ↗
• MalfunctionJun 23, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT HEMOVAC DRAIN SYSTEM DISCONNECTED WHEN THE PATIENT GOT OUT OF BED TO THE CHAIR. ALSO, CUSTOMER END UP TAPING THE ENDS OF THE PORT THAT WAS NOT CONNECTED TO THE HEMOVAC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054776 ↗
• MalfunctionJul 2, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A FOREIGN ITEM IN THE TUBING OF THE WOUND DRAIN.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7654909 ↗