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

Model Number 0165PL10

Device Problem Component Missing (2306)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

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 one piece of origin was missing in foley catheter.

Event Description

It was reported that one of the pediatric foley catheter was missing from the package.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿operator/machine error¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed as labeling review could not have prevented this issue.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.

• Brand Name: BARDEX LUBRICATH PEDIATRIC FOLEY CATHETER
• Type of Device: LATEX FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11367284
• MDR Text Key: 233192494
• Report Number: 1018233-2021-00730
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017674
• UDI-Public: (01)00801741017674
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 0165PL10
• Device Catalogue Number: 0165PL10
• Device Lot Number: NGDR3014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other