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

Model Number	0102L14
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
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 the balloon would not inflate with saline in the catheter.Per follow up via phone on 17nov2020, the catheter inflated with 10cc, but the balloon would not inflate.The catheter was removed and replaced.The customer noted that the catheter inflated with the sterile water, but not with the saline.Also, the catheters changed color to white after a week of use.
Additional Manufacturer Narrative
The reported event was unconfirmed since the device meets specifications.No root cause could be found because the reported event was unconfirmed.Received one red lubricath foley catheter without original packaging.No notable defects were seen on the catheter.The catheter was inflated with 10cc of distilled water.The balloon inflated asymmetrically, and settled at approximately 60:40 symmetry which meets specification.The catheter was left to sit for about 10 minutes.The catheter was then deflated.No holes, leaks, or any abnormalities were seen.The reported event was unconfirmed as the catheter was able to inflate.The product meets specification, as it would pass the functional leak testing.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 the reported event was unconfirmed.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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the balloon would not inflate with saline in the catheter.Per follow up via phone on 17nov2020, the catheter inflated with 10cc, but the balloon would not inflate.The catheter was removed and replaced.The customer noted that the catheter inflated with the sterile water, but not with the saline.Also, the catheters changed color to white after a week of use.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER TIEMANN MODEL COUDE
• Common Device Name: FOLEY CATHETER TIEMANN MODEL COUDE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10978860
• Report Number: 1018233-2020-21560
• Device Sequence Number: 2322765
• Product Code: EZC
• UDI-Device Identifier: 00801741018114
• UDI-Public: (01)00801741018114
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• 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: 08/31/2024
• Device Model Number: 0102L14
• Device Catalogue Number: 0102L14
• Device Lot Number: NGEPY837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 08/30/2021
• 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