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

Device Problems Difficult to Insert (1316); Nonstandard Device (1420); Contamination /Decontamination Problem (2895)

Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199)

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 syringe had barbs inside and the skin pulled up when pulling out the catheter.Per additional information received via phone on 06-feb-2020, it was reported that the catheter was difficult to remove due to barbs on the end of the foley and not on the syringe as previously reported from the facility.Per additional complaint, it was reported that the syringe was difficult to insert into the inflation port.

Event Description

It was reported that the syringe had barbs inside and the skin pulled up when pulling out the catheter.Per additional information received via phone on 06feb2020, it was reported that the catheter was difficult to remove due to barbs on the end of the foley and not on the syringe as previously reported from the facility.Per additional complaint, it was reported that the syringe was difficult to insert into the inflation port.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿bond failure¿ with a potential root cause of ¿poor balloon design¿.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bard is unable to determine the associated labeling to review.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.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9768917
• MDR Text Key: 184648870
• Report Number: 1018233-2020-01412
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1