MAUDE Adverse Event Report: BARD MEDICAL; BARD'S FOLEY CATHETER IN MAJOR PACK

Catalog Number	DYNJ905035
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient required the foley catheter for procedural time greater than 2 hours and for the surgeon to visualize where the ureters are.Per report, the foley catheter was placed approximately 11.5 hours before it was noted that the balloon burst.Immediately after the incident, the catheter was inspected and appeared to all be intact despite being broken.It was reported that during insertion of the foley catheter that burst, the lubricant from the insertion kit was used.It is unknown how much water was used to inflate the balloon since it was the physician who placed the foley catheter.The foley catheter was not tested for inflation or deflation prior to insertion.There was no serious injury or follow-up care reported related to the event.A new foley catheter was inserted.Due to the reported need for foley catheter re-insertion, this medwatch is being filed.The sample was returned for evaluation.A third party notification has been completed with the manufacturer of the foley catheter involved with this event.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the foley catheter's balloon burst requiring a new foley catheter to be inserted.
Additional Manufacturer Narrative
The foley catheter that the reporting facility reported as having a balloon that burst did not originate from medline's major pack.Bard's foley catheter is not found within the bill of materials of this major pack.There is also no record of a bard foley catheter going into any custom surgical packs that medline manufactures for the reporting facility.The reporting facility was notified of this.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

• Common Device Name: BARD'S FOLEY CATHETER IN MAJOR PACK
• Manufacturer (Section D): BARD MEDICAL; 8195 industrial boulevard; covington GA 30014
• MDR Report Key: 7784241
• Report Number: 1423395-2018-00046
• Device Sequence Number: 1117085
• Product Code: LRO
• UDI-Device Identifier: 10889942806560
• UDI-Public: 10889942806560
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ905035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Weight: 87