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

Catalog Number UNKNOWN

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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 experienced leaking around the catheter, even though the urine seemed to be adequately draining into the collection bag.

Event Description

It was reported that the patient experienced leaking around the catheter, even though the urine seemed to be adequately draining into the collection bag.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to ¿bad fit with connector".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the silicone catheter ifus were 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: UNKNOWN SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10315712
• MDR Text Key: 201008848
• Report Number: 1018233-2020-04721
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1