MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FOLEY TRAY WITH LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

Catalog Number	947316
Medical Device Problem Codes	Gel Leak (1267); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
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.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that the inside this product comes an accessory, called urinary catheter lubrication gel.This accessory was chemically changed, that is, the client indicates that it came dry inside the packaging, for this reason it could not be used, that is, this lubricant was used so that the urinary catheter passes through the urinary meatus without resistance and more soft.It was stated that no impact on the patient.
Event or Problem Description
It was reported that the inside this product comes an accessory, called urinary catheter lubrication gel.This accessory was chemically changed, that is, the client indicates that it came dry inside the packaging, for this reason it could not be used, that is, this lubricant was used so that the urinary catheter passes through the urinary meatus without resistance and more soft.It was stated that no impact on the patient.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted received 3 photo samples.First photo sample shows top overview of product packaging with damaged gel syringe next to product packaging.Second photo sample shows top view of damaged syringe and product lot number and expiration date.Third photo sample shows close up of damaged syringe with gel remnants on the side of the syringe.Based on the sample received product does not meet specifications which states "missing, damaged, leaking, ripped, cracked and incomplete components are not allowed.".The exact root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be inappropriate package design.However, there was insufficient information to confirm this potential root cause.A dhr review did not show any problems or conditions that would have contributed to the reported event.The labelling review is not required as labelling would not have prevented the reported event.Section a through f - the information provided by bd represents all 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: BARD® FOLEY TRAY WITH LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18159736
• Report Number: 1018233-2023-08235
• Device Sequence Number: 8045753
• Product Code: EZL
• UDI-Device Identifier: 00801741024931
• UDI-Public: (01)00801741024931
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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: 12/31/2024
• Device Catalogue Number: 947316
• Device Lot Number: NGGU3904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown