MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MALE EXTERNAL CATHETER; UNK MEC

Model Number 802001

Device Problems Backflow (1064); Restricted Flow rate (1248)

Patient Problems Urinary Tract Infection (2120); Patient Problem/Medical Problem (2688)

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 urine backed up into the male external catheter and the patient believed that this was the cause of his urinary tract infections.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿tip i.D too small¿.A potential root cause for this failure could be ¿incorrect diameter on form".The lot number is unknown; therefore, the device history record could not be reviewed.The product code for this z635 product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product code is unknown, the male external 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.

Event Description

It was reported that urine backed up into the male external catheter and the patient believed that this was the cause of his urinary tract infections.The extend of treatment is unknown.

• Brand Name: MALE EXTERNAL CATHETER
• Type of Device: UNK MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9886301
• MDR Text Key: 186542147
• Report Number: 1018233-2020-02154
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741040740
• UDI-Public: (01)00801741040740
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 802001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other