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

Model Number	35303
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
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 if the patient laid there and drink water, it start filling up then the male external catheter would fall off.Patient had been using the products for more than 90 days (batch# jufw0493).Per investigator notification received on 17feb2022.It was stated that the three lots were received for this complaint: (batch# jufu2520), (batch# jufw1132) and (batch# jufv9017) per notification from investigator based on sample evaluation on 26jul2022, it was reported that the male external catheter had strong adhesive (batch# jufw1132).
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.Although an exact root cause could not be determined a potential root cause could be mechanical failure.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 it would not have prevented the reported event.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the if the patient laid there and drink water, it start filling up then the male external catheter would fall off.Patient had been using the products for more than 90 days (batch# jufw0493).Per investigator notification received on 17feb2022.It was stated that the three lots were received for this complaint: (batch# jufu2520), (batch# jufw1132) and (batch# jufv9017) per notification from investigator based on sample evaluation on 26jul2022, it was reported that the male external catheter had strong adhesive (batch# jufw1132).

• 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: 15192558
• Report Number: 1018233-2022-06197
• Device Sequence Number: 17543542
• Product Code: NNX
• UDI-Device Identifier: 00801741070945
• UDI-Public: (01)00801741070945
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/14/2022

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 Expiration Date: 09/28/2026
• Device Model Number: 35303
• Device Catalogue Number: 35303
• Device Lot Number: JUFW1132
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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: Unknown