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

Model Number 0165L16

Device Problem Material Fragmentation (1261)

Patient Problems Cramp(s) (2193); Foreign Body In Patient (2687); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the indwelling catheter was placed when the epidural placement was done and the patient delivered vaginally on (b)(6) 2020.According to the delivered obstetrician, the catheter came out pushing.And the patient was noted tiny fragment of the tip of the urinary catheter expelled during the shower.It was noted that due to the time difference between the delivery and the visit to the physician¿s office and (b)(6) did not have the original catheter and unsure of the lot number (ngev1569)  which was used on the patient back in (b)(6).

Manufacturer Narrative

The reported event was inconclusive because no sample was returned it was unknown whether the device had met relevant specifications.The product was used for urine collection.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be operator error, mechanical failure, user related (eg: pulled by user).The lot number was unknown; therefore, the device history record could not be reviewed.A review of the device labeling have been conducted for investigation purpose."warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not 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.

Event Description

It was reported that the indwelling catheter was placed when the epidural placement was done and the patient delivered vaginally on (b)(6) 2020.According to the delivered obstetrician, the catheter came out pushing.And the patient was noted tiny fragment of the tip of the urinary catheter expelled during the shower.It was noted that due to the time difference between the delivery and the visit to the physician¿s office and memorial medical center did not have the original catheter and unsure of the lot number (ngev1569)  which was used on the patient back in (b)(6).Per customer via email on 03feb2021, stated that the retrieved piece was not available to return and no additional intervention was required because of the event.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11274117
• MDR Text Key: 230253098
• Report Number: 1018233-2021-00252
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017483
• UDI-Public: (01)00801741017483
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0165L16
• Device Catalogue Number: 0165L16
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other