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

Catalog Number UNKNOWN

Device Problems Burst Container or Vessel (1074); Material Rupture (1546); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the nurse flushed the bladder, the catheter was found to be out and the balloon ruptured.The nurse was given a new indwelling of the three lumen catheter.Per additional information via email from ibc on 02sep2020, no, there was no missing pieces.But the sample has been discarded so no other further information could be obtained.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.The potential root cause for this failure mode could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/ operator error.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the foley catheter product 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.

Event Description

It was reported that the nurse flushed the bladder, the catheter was found to be out and the balloon ruptured.The nurse was given a new indwelling of the three lumen catheter.Per additional information via email from ibc on 02sep2020, no, there was no missing pieces.But the sample has been discarded so no other further information could be obtained.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: LATEX FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10525633
• MDR Text Key: 207714903
• Report Number: 1018233-2020-05843
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 11/29/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1