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

Model Number	35302
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
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 were leaking and did not hold.Per follow-up information received from ibc on 25oct2022, stated that 54 catheters were received from the patient.The patient had been using male external catheters for over 7 years and there had been no problems with them so far.The patient was completely paralyzed, they were lying down, or used a specially adapted wheelchair and the carer of this patient reported the problem with catheters.Per notification from investigator on (b)(6) 2022, during sample evaluation strong adhesive was found while testing.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing related.Visual evaluation noted 57 mec's were received with original closed packaging with no obvious defects.Samples were cut to the requirement width 1.00" +/- 0.05" for testing.All test samples did not meet the test specification range of 1.00-3.60 lbfs as strong adhesive was found during testing.Therefore, product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be operator error.The product was not used for patient diagnostic or treatment.The product was influenced by the reported event.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 prevent the reported event.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.
Event or Problem Description
It was reported that the male external catheters were leaking and did not hold.Per follow-up information received from ibc on 25oct2022, stated that 54 catheters were received from the patient.The patient had been using male external catheters for over 7 years and there had been no problems with them so far.The patient was completely paralyzed, they were lying down, or used a specially adapted wheelchair and the carer of this patient reported the problem with catheters.Per notification from investigator on 17nov2022, during sample evaluation strong adhesive was found while testing.

• 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: 15912602
• Report Number: 1018233-2022-09212
• Device Sequence Number: 11385912
• Product Code: NNX
• UDI-Device Identifier: 00801741070938
• UDI-Public: (01)00801741070938
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 12/29/2022

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: 35302
• Device Catalogue Number: 35302
• Device Lot Number: JUGS0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 12/04/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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: Unknown