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

Model Number	7283
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
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 customer thought that they were doing something wrong when they were unable to connect a bag to the male external catheter.The representative went to help and found a faulty sheath.One of the male external catheter was found to be having the outlet on the funnel of the sheath closed off.The outlet should be open to allow urine to drain.They checked all other sheaths in the box and found that other sheaths were okay.Per additional information via email from ibc on (b)(6) 2022, it was stated that the defect found while being used.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Visual evaluation noted received one photo sample that shows used catheter with no original packaging.Photo sample shows tip of catheter not cut off.Therefore, product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be worn or damaged cutting knives or incorrect cut pressure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review is 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 evaluated.
Event or Problem Description
It was reported that the customer thought that they were doing something wrong when they were unable to connect a bag to the male external catheter.The representative went to help and found a faulty sheath.One of the male external catheter was found to be having the outlet on the funnel of the sheath closed off.The outlet should be open to allow urine to drain.They checked all other sheaths in the box and found that other sheaths were okay.Per additional information via email from ibc on 22mar2022, it was stated that the defect found while being used.
Event or Problem Description
It was reported that the customer thought that they were doing something wrong when they were unable to connect a bag to the male external catheter.The representative went to help and found a faulty sheath.One of the male external catheter was found to be having the outlet on the funnel of the sheath closed off.The outlet should be open to allow urine to drain.They checked all other sheaths in the box and found that other sheaths were okay.Per additional information via email from ibc on 22mar2022, it was stated that the defect found while being used.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Visual evaluation noted received one photo sample that shows used catheter with no original packaging.Photo sample shows tip of catheter not cut off.Therefore, product does not meet specifications.Also received 1 used mec sample closed off at the bottom of the sheath.Therefore based on samples received, the product does not meet specification.Although an exact root cause could not be determined a potential root cause could be worn or damaged cutting knives or incorrect cut pressure.Dhr review did not show any problems or conditions that would have contributed to the reported event.Labelling review is 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 evaluated.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16637405
• Report Number: 1018233-2023-02140
• Device Sequence Number: 15047844
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2023

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: 7283
• Device Catalogue Number: 37302
• Device Lot Number: JUGU9094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 04/10/2023; 05/02/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 04/11/2023; 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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