MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK MALE EXTERNAL CATHETER KIT

Model Number PWM030

Device Problem Sharp Edges (4013)

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

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the plastic piece on the purewick male catheter was stabbing at the back of the patient through the bed.It was stated that the sharp object was stripping the bed.It was reported that the patient was supposed to begin new product implementation on that day but decided to postpone and stated that they would need to visit the product with their appropriate committee.

Manufacturer Narrative

The reported event was inconclusive because of a lack of information.A photo sample of the purewick male catheter was returned.Based on the photo, unable to determine of the device caused irritation of the patient skin.A potential root cause for this failure could be due to "inadequate material selection, materials of construction are not biocompatible or material surface is rough, abrasive or uncomfortable".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: do not use on irritated or compromised skin.To avoid potential skin injury, never pull the device directly away from the patient.Always peel in the direction from head to foot.Discontinue use if an allergic reaction occurs.Precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the device.Experiencing skin irritation or breakdown at the site.Always assess skin for compromise and perform perineal care prior to placement of a new device.Recommendations: perform each step with clean technique.Ensure the device remains connected after turning the patient, monitoring for pulling and tension on the device.Remove the device prior to ambulation.Assess device placement and patient¿s skin at least every 2 hours.Maintenance: replace the device at least every 24 hours or if soiled with feces, blood, or semen.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 inspected.

Event Description

It was reported that the plastic piece on the purewick male catheter was stabbing at the back of the patient through the bed.It was stated that the sharp object was stripping the bed.It was reported that the patient was supposed to begin new product implementation on that day but decided to postpone and stated that they would need to visit the product with their appropriate committee.

• Brand Name: PUREWICK MALE EXTERNAL CATHETER KIT
• Type of Device: PUREWICK MALE EXTERNAL CATHETER KIT
• 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: 16071013
• MDR Text Key: 306620912
• Report Number: 1018233-2022-09991
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741219153
• UDI-Public: (01)00801741219153
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

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
• Device Operator: Health Professional
• Device Model Number: PWM030
• Device Catalogue Number: PWM030
• Device Lot Number: NGGU1138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2022
• 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
• Patient Sex: Male