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

Model Number	7283
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the patient was struggling to get the male external catheter off and stated that there was a fault with the sheaths.Stated that the user had the same issue with the same product and lot number with 2 different customers.
Event or Problem Description
It was reported that the patient was struggling to get the male external catheter off and stated there was a fault with the sheaths.It was also stated that the user had the same issue with the same product and lot number with 2 different customers.
Additional Manufacturer Narrative
The reported event was unconfirmed, as the product meet the specifications.Visual evaluation noted 4 unopened hydrocolloid adhesive sheath male external catheters were received.No obvious defects were noted.The samples were cut to the required width (0.70"+/- 0.05").The adhesive peel strength was found to be within the specification (0.60-2.10lbf).The product was not used for diagnosis or treatment.It was determined that the product had no relationship with the event due to the investigation being unconfirmed through the sample evaluation.The product had met specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the 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 actual/suspected device was inspected.

• Brand Name: SPIRIT HYDROCOLLOID ADHESIVE SHEATH
• Common Device Name: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10962228
• Report Number: 1018233-2020-21476
• Device Sequence Number: 559091
• Product Code: NNX
• UDI-Device Identifier: 00801741071645
• UDI-Public: (01)00801741071645
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/28/2025
• Device Model Number: 7283
• Device Catalogue Number: 37302
• Device Lot Number: JUER1567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other