MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC ULTRAFLEX I 30BX; MALE EXTERNAL CATHETER

Catalog Number 97532

Device Problem Nonstandard Device (1420)

Patient Problems Pain (1994); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that patient soaked 35 minutes for one male external catheter and soaked 1-1.5 hours for another male external catheter to remove.Also stated that upon removal patient experienced pain and skin irritation.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.No sample was returned for evaluation.A potential root cause for this failure could be due to "operator error".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.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bard 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 bard.

Event Description

It was reported that patient soaked 35 minutes for one male external catheter and soaked 1-1.5 hours for another male external catheter to remove.Also stated that upon removal patient experienced pain and skin irritation.No medical intervention was reported.

• Brand Name: ROCHESTER MEC ULTRAFLEX I 30BX
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11319801
• MDR Text Key: 232858581
• Report Number: 1018233-2021-00444
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 97532
• Device Lot Number: JUEN3217
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other