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

Model Number	35304
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
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.The device was not returned.
Event or Problem Description
It was reported that the male external catheters did not have drainage and the patient wanted to send 23 back.It was noted that the patient had been using the product for less than 90 days.
Additional Manufacturer Narrative
The reported event is inconclusive as the evaluated representative sample meets specifications and the condition of the used original sample is unknown.Visual evaluation noted 23 unopened male external catheters and 1 male external catheter in opened packaging was received.13 samples were analyzed.Samples were analyzed by observing to see if tip was cut off properly.All samples analyzed showed that the tip was cut properly and nothing was obstructing the tip that would cause drainage issues.Therefore, product meets specifications.Although an exact root cause could not be determined a potential root cause could be incorrect cut pressure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "description / indication: the self-adhering male external catheter is designed for the management of adult male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury or illness of the patient.Precaution: do not use if allergic reaction occurs or if patient has known allergies to device components.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Follow directions to remove if experiencing swelling, numbness, discomfort, pain, discoloration, or abnormal appearance.Note: if experiencing problems with use of the device, please consult your healthcare professional for assistance.Directions to apply: 1) verify correct size prior to use.2) trim pubic hair if necessary.3) wash penis with mild soap and warm water.Dry thoroughly.Wear time may be reduced if skin is not dry or cream/oil is used.4) open package at perforation.Remove catheter from plastic insert, if present.5) place rolled end over the end of the penis, leaving a small space between the end of the penis and the cone of the catheter.6) unroll the catheter over penis.7) gently squeeze the catheter to properly seal adhesive to the skin.If possible, avoid leaving a rolled ¿collar¿ around the base of the penis.Important: wear time may be reduced if adhesive is not properly sealed to the skin.8) connect the catheter to a drainage system.Make sure to check that connections are secure before use.Directions to remove: 1) ensure drainage bag is empty drainage system.3) gently roll the catheter forward and off the penis.If necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.Disposal: after removal, dispose by placing the used catheter into a waste container." 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 or Problem Description
It was reported that the male external catheters did not have drainage and the patient wanted to send 23 back.It was noted that the patient had been using the product for less than 90 days.Per additional information from cardinal health, it was reported that the male external catheters did not work and stated that there was no drainage.Per additional information via form with sample returned on 22feb2022, it was reported that the male external catheter had bad drainage between catheter and the tube.

• Brand Name: SPIRIT® HYDROCOLLOID ADHESIVE SHEATH
• Common Device Name: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13271382
• Report Number: 1018233-2022-00053
• Device Sequence Number: 4950933
• Product Code: NNX
• UDI-Device Identifier: 00801741070952
• UDI-Public: (01)00801741070952
• 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): 07/22/2022

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: 03/28/2026
• Device Model Number: 35304
• Device Catalogue Number: 35304
• Device Lot Number: JUFR1322
• 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: 12/28/2021
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 52 KG
• Patient Race: White