MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALL SILICONE CATHETER

Device Problems Deflation Problem (1149); Inflation Problem (1310); Device Fell (4014)

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 patient was transferred to ccu and the catheter fell out and inserted three times due to the balloons being partially inflated.( foley was sterilized before inserting back into patient).

Event Description

It was reported that when the patient was transferred to the ccu, the catheter fell out and was inserted three times due to the balloons being partially inflated.(the foley was sterilized before being inserted back into the patient).

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿balloon collapses¿ with a potential root cause of " inflation / drainage lumen wall perforated".The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review is not required as the product code for this z03 product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product code is unknown, the all silicone catheter product labeling is found to be adequate based on past reviews.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: ALL SILICONE CATHETER
• Type of Device: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9800579
• MDR Text Key: 185226474
• Report Number: 1018233-2020-01609
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1