MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. COUNCILL MODEL FOLEY CATHETER

Model Number	0196SI20
Medical Device Problem Codes	Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/1980
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 the foley catheter was defective and contaminated.Per follow-up information received via email on 15dec2020, the customer stated that the balloon emptied approximately 2-3 cc fluid.The resistance was met when attempting to remove the tube and the physician stated that the resistance was as normal as the tube passed through the fascia.The patient attempted to remove again, resistance was met, slightly added more pressure and the tube was successfully removed and the balloon appeared to remain semi-inflated.The patient experienced self limited bleeding at the left incision site and the bleeding was stopped after applying the pressure at the left incision site.
Event or Problem Description
It was reported that the foley catheter was defective and contaminated.Per follow-up information received via email on 15dec2020, the customer stated that the balloon emptied approximately 2-3 cc fluid.The resistance was met when attempting to remove the tube and the physician stated that the resistance was as normal as the tube passed through the fascia.The patient attempted to remove again, resistance was met, slightly added more pressure and the tube was successfully removed and the balloon appeared to remain semi-inflated.The patient experienced self limited bleeding at the left incision site and the bleeding was stopped after applying the pressure at the left incision site.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device did not fail to meet relevant specifications.The reported failure was able to be reproduced.The product was used for treatment purposes.A potential root cause for this failure could be "defective/ with contamination components from the supplier".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not required, as the reported event was unlikely to be caused by the user.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 actual/suspected device was inspected.

• Brand Name: BARDEX I.C. COUNCILL MODEL FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11096357
• Report Number: 1018233-2020-22160
• Device Sequence Number: 17108359
• Product Code: MJC
• UDI-Device Identifier: 00801741017032
• UDI-Public: (01)00801741017032
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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: 11/30/2024
• Device Model Number: 0196SI20
• Device Catalogue Number: 0196SI20
• Device Lot Number: NGET1943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 09/27/2021
• 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