MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN SILICONE CATHETER; 8FR SILICONE FOLEY CATHETER

Device Problems Material Invagination (1336); Material Twisted/Bent (2981)

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.

Event Description

It was reported that a part of the silicone rolled up and caused a barrier making it difficult to be remove.

Manufacturer Narrative

The reported event was confirmed.The product was used for treatment.The product was out of specification.The product was influenced by the reported failure.Visual evaluation of the sample noted one used silicone foley without original packaging.The catheter balloon was noted to be cuffing.The device specification could not be found as the product identity was unknown, but this failure is typically of specification as it interferes with the general function of the catheter.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be incorrect 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/bd is unable to determine the associated labeling to review.

Event Description

It was reported that a part of the silicone rolled up and caused a barrier making it difficult to be remove.

• Brand Name: UNKNOWN SILICONE CATHETER
• Type of Device: 8FR SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9194267
• MDR Text Key: 179751643
• Report Number: 1018233-2019-06512
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1