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

Model Number 0165L28

Device Problems Incorrect Measurement (1383); Expiration Date Error (2528); Protective Measures Problem (3015)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the catheter diameter seemed to be off.One side of the catheter measured correctly, however the other side was off in dimension.

Manufacturer Narrative

The device was not returned for evaluation.The reported event is inconclusive as no sample was returned for evaluation.A potential root cause could be due to the ¿operator error or machine malfunction" or "user not familiar with product".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use." 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 device was not returned.

Event Description

It was reported that the catheter diameter seemed to be off.One side of the catheter measured correctly, however the other side was off in dimension.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.An amber lubricath was returned open without its original packaging.The catheter's date code was listed as hc4281 has an expiration date of 03jun2019.The provided corporate lot number has an even earlier expiration date (as expected) of 28feb2019.The preliminary evaluation photo sample showed signs of white degradation on the catheter.The photo sample also showed that one of the eyes was larger than the other.However as the catheter had been expired months before the date of awareness of 31mar2020, this investigation would be confirmed for "expiration date exceeded" and not "incorrect measurements".As the original packaging was not returned, the investigation would not be confirmed as use-related.A potential root cause could be that the user was unfamiliar with the product or a damaged label.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.".

Event Description

It was reported that the catheter diameter seemed to be off.One side of the catheter measured correctly, however the other side was off in dimension.It was later reported from the complainant via voicemail on 25jun2020, that there was no problem with the diameter of the catheter, the issue was with the eyelets.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: FOLEY CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9978096
• MDR Text Key: 188488572
• Report Number: 1018233-2020-02717
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017544
• UDI-Public: (01)00801741017544
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: 0165L28
• Device Catalogue Number: 0165L28
• Device Lot Number: NGZA2216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/20/2020
• Supplement Dates Manufacturer Received: 05/27/2020; 07/13/2020
• Supplement Dates FDA Received: 06/16/2020; 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 DA