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

Catalog Number PWM030

Device Problems Loss of or Failure to Bond (1068); Positioning Failure (1158)

Patient Problems Unspecified Infection (1930); Skin Tears (2516)

Event Date 04/28/2023

Event Type  Injury  

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.H3 other text : the device was not returned.

Event Description

It was reported that patients and staff reported that patients skin trying to hold the purewick in place.They use diapers, chucks and a lot of tape that is damaging patients skin and causing infections.It was unknown what medical intervention was provided.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "inadequate material selection and/or wall thickness, does not withstand transportation conditions or degrades over time." the lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "peri-care and placement: 3.If there is significant pubic hair, trim or clip the pubic hair.Perform perineal care using the included wipes and assess skin integrity.Follow and document per hospital protocol.Note: use the included drying wipe to ensure skin is dry prior to placement of the device.Moisture on skin will weaken the adhesive.4.Orient the device, aligning drainage fitting towards the feet of the patient.Slide the opening of the device over the penis until close to the pelvic skin.Center penis within the opening.Remove adhesive liner and press the device against the pelvic skin to adhere.Ensure base has fully adhered around the base of the penis.Note: the scrotum should not be placed inside the device." "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.¿ change suction tubing per hospital protocol or at least every thirty (30) days.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.

Event Description

It was reported that the clinical staff that they would be moving away from purewick both male and female.They had to many complaints from patients and staff.The biggest complaint was patients skin trying to hold the purewick in place.They use diapers, chucks and a lot of tape that was damaging patients skin and causing infections.It was unknown what medical intervention was provided.

• 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: 16969816
• MDR Text Key: 315739759
• Report Number: 1018233-2023-03613
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: PWM030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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