MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SPIRIT HYDROCOLLOID ADHESIVE SHEATH; MALE EXTERNAL CATHETER

Model Number 35303

Device Problem Nonstandard Device (1420)

Patient Problem Pain (1994)

Event Date 02/15/2021

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 the male external catheters hurt the patient because of the adhesive.No details were provided.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 lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labeling could not have prevented the reported failure.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 hurt the patient because of the adhesive.No details were provided.No medical intervention was reported.

• Brand Name: SPIRIT HYDROCOLLOID ADHESIVE SHEATH
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11447292
• MDR Text Key: 238704535
• Report Number: 1018233-2021-01158
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070945
• UDI-Public: (01)00801741070945
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

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
• Device Model Number: 35303
• Device Catalogue Number: 35303
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other