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

Model Number	0170SI12
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
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 there was dark matter in the eyelets of the foley catheter when removed from the packaging.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.One sample was confirmed to exhibit the reported failure.A lubrisil ic silicone foley was returned in open original packaging, brown hard tissue like substance noted inside eyelet of catheter.Crystallization occurring during the dipping process was confirmed to be the cause of the foreign material, per moncks quality engineering.Product does not meet specification which states "inspect the catheter for excess coating, damaged coating and occluded eyes" and to "remove and record all scrap on the router and traveler ticket".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 required as the reported event was confirmed as manufacturing related.Corrections: d, h.H11: section a through f - the information provided by bard 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 bard.
Event or Problem Description
It was reported that there was dark matter in the eyelets of the foley catheter when removed from the packaging.

• Brand Name: BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10876876
• Report Number: 1018233-2020-21124
• Device Sequence Number: 3738251
• Product Code: MJC
• UDI-Device Identifier: 00801741025327
• UDI-Public: (01)00801741025327
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K984136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: 0170SI12
• Device Catalogue Number: 0170SI12
• Device Lot Number: NGDV3565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 08/19/2021
• 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