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

Model Number	0165PL10
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that one piece was missing from sealed package of foley catheter - pediatric.
Event or Problem Description
It was reported that one piece was missing from sealed package of foley catheter.
Additional Manufacturer Narrative
The reported event was inconclusive due to poor sample condition.Visual evaluation of the returned sample noted one latex foley within its strip pack and its opened carton packaging.Visual inspection of the sample noted that there may have been some strip packs still left in the carton, but with the angle of the picture, it cannot be confirmed how many catheters were in the carton originally upon receipt.As a result, it cannot be assessed if the carton was truly missing one catheter.A potential root cause for this failure could be "operator 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 because labelling could not have prevented the reported failure.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
• Common Device Name: PEDIATRIC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11297788
• Report Number: 1018233-2021-00345
• Device Sequence Number: 741661
• Product Code: EZC
• UDI-Device Identifier: 00801741017674
• UDI-Public: (01)00801741017674
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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
• Operator of Device: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 08/11/2021
• 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