MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 POP-ON® SELF-ADHERING MALE EXTERNAL CATHETER SMALL 25MM; MEC

Model Number 32301

Device Problems Nonstandard Device (1420); Defective Device (2588)

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 male external catheters did not unroll properly.When they were attached to the penile shaft, it was a matter of time until they came off again.

Manufacturer Narrative

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

Event Description

It was reported that the male external catheters did not unroll properly.When they were attached to the penile shaft, it was a matter of time until they came off again.Per additional information received via email from ibc representative, the complainant did not alleged too much adhesive on the mec.Per sample evaluation, three samples were tested from the lot sample and were found to have weak adhesive.

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿directions: to apply 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) open package at perforation.4) to remove plastic insert, squeeze catheter at the top of the white cone and pull to release." 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.

Event Description

It was reported that the male external catheters did not unroll properly.When they were attached to the penile shaft, it was a matter of time until they came off again.

• Brand Name: POP-ON® SELF-ADHERING MALE EXTERNAL CATHETER SMALL 25MM
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9071124
• MDR Text Key: 164510337
• Report Number: 1018233-2019-05651
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070525
• UDI-Public: (01)00801741070525
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Model Number: 32301
• Device Catalogue Number: 32301
• Device Lot Number: JUCY0404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1