MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER; UNKNOWN FOLEY CATHETER

Device Problems Burst Container or Vessel (1074); Material Rupture (1546); Device Fell (4014)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the catheter ruptured on the 5th day of placement after surgery and the catheter fell off.Second catheter was not placed and the patient was under observation.Per additional received via email on 29 jun 2020, the detached balloon and urethral catheter was complete.

Event Description

It was reported that the catheter ruptured on the 5th day of placement after surgery and the catheter fell off.Second catheter was not placed and the patient was under observation.Per additional received via email on 29jun2020, the detached balloon and urethral catheter was complete.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to a user related (example: contact with sharp objects/ exposure to petrolatum based products/ mechanical failure/ operator error).The lot number was unknown; therefore, the device history record could not be reviewed.The labeling review was unable to perform due to the unknown product code.Although the product family was unknown, the (foley catheter) ifus were found to be adequate based on past reviews.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: UNKNOWN FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10245541
• MDR Text Key: 198694544
• Report Number: 1018233-2020-04389
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1