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

Model Number 38301

Device Problems Inadequacy of Device Shape and/or Size (1583); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 stated the naturals keep falling off using the smallest size.The patient had some retraction.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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.The device was not returned.

Event Description

It was reported that the patient stated the naturals keep falling off using the smallest size.The patient had some retraction.No medical intervention reported.

• Brand Name: NATURAL NON-ADHESIVE 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: 10483786
• MDR Text Key: 206320338
• Report Number: 1018233-2020-05644
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071225
• UDI-Public: (01)00801741071225
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 38301
• Device Catalogue Number: 38301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1