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

Catalog Number UNKNOWN

Device Problems Break (1069); Burst Container or Vessel (1074); Noise, Audible (3273)

Patient Problems Patient Problem/Medical Problem (2688); Insufficient Information (4580)

Event Date 07/31/2020

Event Type  Injury  

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 nurse was irrigating through the urinary drainage bag port, both the patient and the nurse heard a faint ¿pop¿.It was then determined that the catheter balloon had broken.Per additional information received from the complainant on 17sep2020 via email, the device was used on a (b)(6)-year-old female.The irrigation of the device was through the urinary drainage sampling port.The patient was sent to the operation room to determine whether there were any missing pieces of the balloon retained.Per the complainant, that could not be determined.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "non-uniform thin sac and /or finish dip coverage." 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 product 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.

Event Description

It was reported that the nurse was irrigating through the urinary drainage bag port, both the patient and the nurse heard a faint ¿pop¿.It was then determined that the catheter balloon had broken.Per additional information received from the complainant on 17sep2020 via email, the device was used on a thirteen-year-old female.The irrigation of the device was through the urinary drainage sampling port.The patient was sent to the operation room to determine whether there were any missing pieces of the balloon retained.Per the complainant, that could not be determined.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10620012
• MDR Text Key: 209623623
• Report Number: 1018233-2020-06309
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 11/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR