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

Catalog Number PWM030

Device Problem Sharp Edges (4013)

Patient Problem Abrasion (1689)

Event Date 09/14/2022

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 nurse of a patient who had the product placed and let us know that the mesh in the purewick male external catheter had migrated up during a evaluation.Because the mesh migrated up, the suction port flipped back onto the clear plastic.The nurse stated the mesh was soaked with urine and there was urine pooling at the distal end of the device.Also, the squared-off edges of the blue suction port were rubbing against the patient's skin.No medical intervention was reported.

Event Description

It was reported that the nurse of a patient who had the product placed and let us know that the mesh in the purewick male external catheter had migrated up during a evaluation.Because the mesh migrated up, the suction port flipped back onto the clear plastic.The nurse stated the mesh was soaked with urine and there was urine pooling at the distal end of the device.Also, the squared-off edges of the blue suction port were rubbing against the patient's skin.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive because of a lack of information.A photo sample of the purewick male catheter was returned.The inner mess was noted to have folded inside of the catheter bag.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 dhr review is not required as the lot number is unknown.The instructions for use were found adequate and state the following: "warnings: ¿ 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: 6.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 evaluated.

• Brand Name: PUREWICK MALE EXTERNAL CATHETER
• Type of Device: PUREWICK 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15484695
• MDR Text Key: 303794254
• Report Number: 1018233-2022-07428
• Device Sequence Number: 1
• Product Code: NZU
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PWM030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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