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

Device Problems Inadequate Instructions for Healthcare Professional (1319); Missing Information (4053)

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 customer received the male external catheter samples and a measuring tool but did not receive instructions for use.

Event Description

It was reported that the customer received the male external catheter samples and a measuring tool but did not receive instructions for use.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿incorrect labels /incorrect information in labels / data collection¿ with a potential root cause of ¿lack of line clearance or operator error¿.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review as the product catalog number for this device was unknown.Although the product family was unknown, the male external 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.H3 other text : the device was not returned.

• Brand Name: MALE EXTERNAL CATHETER
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10122697
• MDR Text Key: 194624220
• Report Number: 1018233-2020-03624
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 07/05/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1