Aspira Drainage KitRecalls & reported problems across all models

We found 4 models of Aspira Drainage Kit by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Oct 7, 2016 and Jan 8, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “No Device Output” (3 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

Aspira Drainage Kit 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. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1599-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported Aspira Drainage Kit problems

Aspira Drainage Kit models

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

• Aspira Drainage Kit 4992301

  CATHETER, PERITONEAL, LONG-TERM INDWELLING
  1 recall4 reports
• Aspira Drainage Kit 4992209

  CATHETER, PERITONEAL, LONG-TERM INDWELLING
  4 reports
• Aspira Drainage Kit 4992508

  APPARATUS, SUCTION, PATIENT CARE
  2 reports
• Aspira Drainage Kit 4992207

  CATHETER, PERITONEAL, LONG-TERM INDWELLING
  1 report

Recent Aspira Drainage Kit adverse event reports

The 11 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ACCOUNT ALLEGES THAT POST PROCEDURE OF A RIGHT PLEURAL CATHETER, THE LEFT CATHETER CAP BECAME DISLODGED ALLOWING PLEURAL FLUID TO DRAIN AND AIR TO BACKFLOW INTO THE CATHETER. THIS EVENT CAUSED A LEFT-SIDED PNEUMOTHORAX REQUIRING HOSPITALIZATION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 18466551 ↗
• MalfunctionJun 7, 2018Material Frayed; Material Frayed

  IT WAS REPORTED THAT AFTER FLUSHING THE DEVICE, THE INNER STYLET BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7580626 ↗
• MalfunctionApr 17, 2018Insufficient Flow or Under Infusion

  IT WAS REPORTED BY THE PATIENT THAT THE DRAINAGE ON HER ASPIRA BAG HAS DECREASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7438562 ↗
• MalfunctionApr 12, 2018Inflation Problem; No Device Output

  IT WAS REPORTED THAT THE HOME HEALTH NURSE HAS A PATIENT WITH AN ASPIRA PERITONEAL CATHETER THAT WAS PLACED APPROXIMATELY ONE MONTH AGO. SHE REPORTS THAT IT DRAINED PROPERLY AT THE HOSPITAL AND SHE WAS ABLE TO DRAIN IT TWO DAYS AGO. THE PATIENT'S ABDOMEN IS SWOLLEN, BUT THE BULB WILL NOT INFLATE AFTER IT IS SQUEEZED AND FLUID IS NOT DRAINING. SHE STATES THIS HAPPENED WITH TWO BAGS.

  Patient problems: Swelling

  MAUDE report 7426726 ↗
• MalfunctionApr 12, 2018No Device Output

  PATIENT REPORTED THAT HIS ASPIRA BAG WILL NOT DRAIN. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7426451 ↗
• MalfunctionApr 6, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE ASPIRA DRAINAGE CATHETER WAS LEAKING FROM THE HUB. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7404506 ↗
• MalfunctionSep 20, 2017Improper Device Output

  PER MS AND S, THE HOSPICE NURSE CALLED TO REPORT DRAINAGE ISSUES WITH A PATIENT'S ASPIRA CATHETER. AFTER PLACEMENT, HE DRAINED ~1,000 CC. DURING THE LAST TWO DRAINAGE SESSIONS, HE DRAINED ~ 600 CC EACH TIME. TODAY, HE ONLY DRAINED ~ 10 CC. HE EXPERIENCES SHORTNESS OF BREATH EVEN WHEN HE HAS BEEN ABLE TO DRAIN, BUT HIS SHORTNESS OF BREATH IS WORSE SINCE HE ISN'T GETTING MUCH FLUID OUT. THEY TRIED 2 DRAINAGE KITS, BUT THE BULB DID NOT EXPAND AFTER SQUEEZING IT.

  Patient problems: Dyspnea

  MAUDE report 6880290 ↗
• MalfunctionJul 14, 2017No Device Output

  IT WAS REPORTED TO MS&S, THAT THE ASPIRA CATHETER IS NOT DRAINING. FLUID IS PRESENT IN THE TUBING, BUT WILL NOT DRAIN INTO THE BAG. MS&S ADVISED THE COMPLAINANT THAT THE VALVE MAY BE DAMAGED AND NEED TO BE REPLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6715675 ↗
• MalfunctionJun 9, 2017Inflation Problem; Device Operates Differently Than Expected; Output Problem

  ON (B)(6) 2017 - HOSPICE NURSE REPORTED TO MEDICAL SERVICES AND SUPPORT (MS&S) THAT IN HOME PATIENT'S ASPIRA PLEURAL CATHETER HAS NOT BEEN DRAINED SUCCESSFULLY SINCE (B)(6) 2017. NURSE STATED THERE WAS "PINKISH TINTED FLUID" IN THE EXTERNAL SEGMENT. AFTER SQUEEZING THE BULB, THE BULB WOULD NOT RE-INFLATE NOR DRAIN FLUID. MS&S ADVISED THE NURSE THAT THE PATIENT MAY NEED TO BE SEEN IN THE ER SINCE THE CATHETER WILL NOT DRAIN. THE CATHETER COULD BE PARTIALLY OCCLUDED. NURSE CONFIRMED THAT THERE WERE NO KINKS IN THE LINE, NO CLAMP ON THE CATHETER AND THAT THE BAG IS BELOW THE AREA NEEDING TO BE DRAINED. THE BAG/CATHETER CONNECTION WAS CHECKED, PATIENT WAS REPOSITIONED AND AFTER MILKING THE LINE, THE NURSE WAS ONLY ABLE TO GET A FEW MLS TO DRAIN. MS&S STATED THE CATHETER MAY NEED TO BE FLUSHED WITH SALINE OR FIBRINOLYSIS AGENT. THE NURSE DID NOT HAVE A SYRINGE FOR FLUSHING AT THE TIME. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6632469 ↗
• MalfunctionApr 12, 2017Hole In Material

  FACILITY REPORTED TO THE SALES REP THAT THERE IS A HOLE IN THE CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6486055 ↗
• MalfunctionOct 7, 2016Cut In Material

  A REPORTED BY THE FACILITY TO THE DISTRIBUTOR: "THE CATHETER LOOKS LIKE IT'S BEEN CUT WITH A KNIFE BECAUSE THERE'S A HUGE SLIT AT THE TOP OF THE TRAY."

  Patient problems: No Information

  MAUDE report 6010596 ↗

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