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

Model Number 39302

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2023

Event Type  malfunction  

Event Description

It was reported that the male external catheters were not sealed properly and was leaked.Per additional information received on (b)(6) 2023, it was reported that the strong adhesive was found during sample evaluation.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.The device was not returned.

Manufacturer Narrative

The reported event is confirmed - manufacturing related due to strong adhesive found.Visual inspection noted one (1) mec in closed packaging with no obvious defects.Further testing required.Functional evaluation noted adhesive peel test was conducted and 1 sample was tested according to ansi/asqz1.4 c=0 sampling plan, aql- 1.0.Samples were cut to the requirement width 1.00" +/- 0.05" for testing.Sample did not meet the specification of 1.00 lbs ¿ 3.60 lbfs.Strong adhesive was found.Therefore, product did not meet specifications.The 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.A labeling review is not required because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all 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 Description

It was reported that the male external catheters were not sealed properly and was leaked.Per additional information received on 13june2023, it was reported that the strong adhesive was found during sample evaluation.

• Brand Name: SPIRIT® HYDROCOLLOID ADHESIVE SHEATH
• Type of Device: HYDROCOLLOID ADHESIVE SHEATH
• 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: 17237139
• MDR Text Key: 318241399
• Report Number: 1018233-2023-04795
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071331
• UDI-Public: (01)00801741071331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 39302
• Device Catalogue Number: 39302
• Device Lot Number: JUGS1556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other