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

Model Number	39302
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
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 male external catheters from the last box of supplies were not sticking.Per sample evaluation from investigator via email on 16jun2022, a strong adhesive result was found.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing related.Visual evaluation noted 1 male external catheter was received in original packaging with no defects present.However, during sample preparation adhesiveness was found as product crimped up on the sides after cutting it.Therefore, product does not meet specification.Picture of adhesiveness attached in the investigation overview element.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review was not required as labelling would not have prevented the reported event.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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the male external catheters from the last box of supplies were not sticking.Per sample evaluation from investigator via email on 16jun2022, a strong adhesive result was found.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14930666
• Report Number: 1018233-2022-05188
• Device Sequence Number: 13924731
• Product Code: NNX
• UDI-Device Identifier: 00801741071331
• UDI-Public: (01)00801741071331
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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 Model Number: 39302
• Device Catalogue Number: 39302
• Device Lot Number: JUFZ9030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male