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

Model Number PWFX30

Device Problem Device Handling Problem (3265)

Patient Problems Bacterial Infection (1735); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 09/08/2021

Event Type  Injury  

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 Description

It was reported that the hospital left the purewick female external catheter on the patient after they had a bowel movement.It was stated that the wick was covered with feces and urine, which caused the patient to get a flesh-eating disease.Also, was advised that the negligence and training of the nursing staff had nothing to do with the liberator, as it was noted in the purewick manual to not use the product on customers who had fecal incontinence.It was unknown what medical intervention was provided for flesh-eating disease.

Manufacturer Narrative

The reported event is confirmed use related.It was unknown whether the device had met specifications.The product was used for treatment purposes.The failure was caused by the misuse of the product.No sample was returned for evaluation.A potential root cause for the issue could be "patient has fecal incontinence or is menstruating and is unaware of their condition or the restrictions of use." a dhr review was not required because the investigation was confirmed - use related.The instructions for use were found adequate and state the following: " not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter.Having frequent episodes of bowel incontinence without a fecal management system in place.Experiencing skin irritation or breakdown at the site.Experiencing moderate/heavy menstruation and cannot use a tampon ".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 device was not returned.

Event Description

It was reported that the hospital left the purewick female external catheter on the patient after had a bowel movement.It was stated that the wick was covered with feces and urine, which caused the patient to get a flesh-eating disease.It was advised that the negligence and training of the nursing staff had nothing to do with the liberator as it was noted in the purewick manual to not use the product on customers that had fecal incontinence.Per customer via phone on 30nov2021, the hospital staff would remove the wick without cutting the purewick urine collection system off when the wick was changed.The patient stated could feel pain as they tugged to remove it.It was believed that the hospital staff did not place the wick properly and eventually caused broken skin.The wick would stick to the patient¿s skin, the staff was not cleaning the patient well, and it eventually caused flesh eating disease.The patient had four surgeries to control the flesh-eating disease.After the first surgery, the patient felt that the thigh was swollen and red and it had cellulitis.The patient went home on a wound vac and now had a large sore that had to wet-dry pack for healing.The patient continued to be under medical treatment.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: PUREWICK FEMALE 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12546487
• MDR Text Key: 273765021
• Report Number: 1018233-2021-06063
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

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 Model Number: PWFX30
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/13/2021
• 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; Required Intervention
• Patient Sex: Female