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

Device Problems Crack (1135); Fluid/Blood Leak (1250); Fracture (1260)

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 came into facility and a foley was placed in the er.Once the patient was placed on the floor it was noted that the patient was excessively wet.After the removal of the foley, the foley was found to be cracked near the y port and was discarded at that time.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿inadequate seal to connector; funnel falls off connector¿ with a potential root cause of " inadequate material selection".The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review is not required.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.

Event Description

It was reported that the patient came into the facility and a foley was placed in the er.Once the patient was placed on the floor, it was noted that the patient was excessively wet.After the removal of the foley, the foley was found to be cracked near the y port and was discarded at that time.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: SILICONE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9800604
• MDR Text Key: 185227759
• Report Number: 1018233-2020-01608
• 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
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1