BLAKE 2216Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031003521), received between Mar 7, 2018 and Mar 24, 2026 — classified as 4 injuries, 6 malfunctions.

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

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN (B)(6) 2026 A SUTURE WAS USED. IT WAS FOUND THAT THERE WAS A FOREIGN MATTER IN THE PACKAGE. THE PRODUCT WAS NOT USED. THIS EVENT WAS FOUND BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674802 ↗
• InjuryMar 6, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2026 AND DRAIN WAS USED. DR. HAS APPLIED SILICONE DRAINAGE TO THE ABDOMINAL AT THE (B)(6) 2026. ON THE (B)(6) 2026 AT DRAINAGE REMOVAL, THE DRAIN BROKE OFF AND THE TAIL REMAINED IN THE ABDOMINAL WALL. HE HAD TO REMOVE THE DRAINAGE RESIDUE IN THE OPERATING ROOM UNDER LOCAL ANESTHESIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24532375 ↗
• InjuryNov 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS PLACED. THE DRAIN WAS TO BE REMOVED ON (B)(6) 2025. ABOUT 10-15 CM OF THE REDON WITH WHITE BLADE EXIT THEN IMPOSSIBLE TO BRING OUT THE REST. INFORMATION TO THE SURGEON TO KNOW WHAT TO DO: TRY AGAIN TO REMOVE ON THE DRAIN. TRY BY OTHER COLLEAGUE WHO ALSO FEEL THE BLOCKAGE TO REMOVE THE DRAIN. RELAY PASSED TO ANOTHER COLLEAGUE: THE DRAIN COMES OUT BUT THE END SEEMS LIKE CUT, RESTEDE REDON INSIDE? PERFORM AP CT WITHOUT INJECTION FOR MONITORING. CT REPORT CONFIRMS THE PRESENCE OF THE REST OF REDON IN THE PATIENT'S BODY. WITHDRAWAL OF REDON UNDER GENERAL ANESTHESIA (B)(6) 2025. ABDOMINOPELVIEN XRAY: INDICATION: SEARCH FOR AN INTRA-ABDOMINAL FOREIGN BODY. TECHNIQUE: HELICAL SCAN PERFORMED WITHOUT INJECTION. RESULTS: THE PRESENCE OF A REDON TIP CORRESPONDING TO THE END OF THE REDON SITUATED OPPOSITE THE SUBCUTANEOUS FAT IN FRONT OF THE ABDOMINAL WALL IS CONFIRMED. THE REST OF THE BALANCE SHEET IS UNREMARKABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23616318 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST CANCER SURGERY ON (B)(6) 2024 AND A DRAIN WAS USED. DURING USE THE DRAIN TUBE WAS BROKEN AT THE ICU. THE PRODUCT WAS USED ON THE CHEST. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761556 ↗
• InjuryNov 10, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT ON (B)(6) 2023 AND A DRAIN WAS USED. THE INSTALLATION OF THIS DRAIN WENT WELL. WHEN THE DRAIN WAS REMOVED BY THE NURSE, THE DRAIN WAS CUT AND A 12 CM FRAGMENT REMAINED IN THE BODY. THIS FRAGMENT WAS REMOVED IN INTENSIVE CARE. THE PATIENT SUFFERED SEPTIC SHOCK AND WAS TREATED WITH APPROPRIATE ANTIBIOTICS. THE FRAGMENT WAS REMOVED IN THE OPERATING ROOM AND TRANSFERRED TO INTENSIVE CARE. THE PATIENT WAS TRANSFERRED TO ANOTHER DEPARTMENT AND PROLONGATION OF HOSPITALIZATION. ADDITIONAL INFORMATION

  Patient problems: Foreign Body In Patient; Septic Shock

  MAUDE report 18113542 ↗
• MalfunctionApr 13, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE, AND A DRAIN WAS USED. DURING USE, THE TIP OF THE TROCAR, WHICH SHOULD HAVE BEEN SHARP, HAD BEEN BENT AND IT WAS DIFFICULT TO PENETRATE THE SKIN. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON RECEIPT OF SAMPLE AND ANALYSIS THE SHARP EDGES OF THE TROCARS WERE FOUND TO BE IN BENT CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16736967 ↗
• MalfunctionApr 13, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. DURING USE, THE TIP OF THE TROCAR, WHICH SHOULD HAVE BEEN SHARP, HAD BEEN BENT AND IT WAS DIFFICULT TO PENETRATE THE SKIN. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON RECEIPT OF SAMPLE AND ANALYSIS THE SHARP EDGES OF THE TROCARS WERE FOUND TO BE IN BENT CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16736963 ↗
• InjuryJan 31, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN HEPATO BILIARY PANCREATIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. WHEN REMOVING THE DRAIN, IT BROKE INSIDE OF THE BODY. BROKEN PIECE REMAINED INSIDE OF THE BODY. IT WAS REMOVED DURING A RE-OPERATION. THE SURGERY WAS A SURGICAL PROCEDURE INVOLVED THE HEPATOBILIARY PANCREATIC REGION, AND THE PRODUCT WAS USED UNDER THE RIGHT DIAPHRAGM. REMOVAL WAS PERFORMED 6 DAYS AFTER SURGERY. IT WAS FOUND THAT THE JOINT OF THE DRAIN WAS FRACTURED. AFTER THAT, THERE HAS BEEN NO ADVERSE CONSEQUENCE TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16270924 ↗
• MalfunctionSep 19, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2022 AND A DRAIN WAS USED. DURING SURGERY, THE DRAIN WAS CRUSHED AND THEN GOT CLOGGED SO DRAINAGE COULD NOT BE DONE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445348 ↗
• MalfunctionMar 7, 2018Break; Break

  IT WAS REPORTED THAT, THE DRAIN WAS BROKEN WHEN TRYING TO REMOVE IT AFTER A CAESAREAN SECTION PROCEDURE IN WHICH THE DRAIN WAS PLACED. THE SITUATION WAS AS FOLLOWS: ON (B)(6), THE DRAIN WAS PLACED INSIDE THE PATIENT¿S BODY FOR SUBCUTANEOUS DRAINAGE. FIVE DAYS AFTER THE OPERATION, WHEN TRYING TO REMOVE THE DRAIN, THE SURGEON FELT THAT THE DRAIN WAS CAUGHT INSIDE THE PATIENT¿S BODY. THEN, THE TIP OF THE DRAIN WAS BROKEN OFF WHEN PULLING OUT THE DRAIN FROM THE PATIENT¿S BODY BY EXCESSIVE FORCE. THE BROKEN PIECE OF THE DRAIN WAS RETRIEVED. BY X-RAY INSPECTION, IT WAS CONFIRMED THAT NO PIECE OF THE DRAIN REMAINED IN THE PATIENT¿S BODY. THE SURGEON COMMENTED AS FOLLOWS; INTERRUPTED SUTURING WAS PERFORMED UNDER THE SKIN DURING THE OPERATION. THERE IS A POSSIBILITY THAT THE DRAIN MIGHT HAVE BEEN FIXED WITH THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7320678 ↗