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

Device Problem Device Handling Problem (3265)

Patient Problems Diarrhea (1811); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2022

Event Type  Injury  

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 user facility had multiple complaints with the purewick female external catheter.And the full success rate of the catheter was only about 25 to 45 percentage.The first issue was many patients experienced diarrhea and leaking stools and soiled with feces, blood and the purewick seems to have an issue with soaking up the fecal matter which would lead to an infection of the vagina if not addressed immediately and cared for.The second issue was the purewick female external catheters were move out of the proper position if the patient was thinner, for example, a 5'6" woman under 145 pounds and subsequently not absorbing the urine properly.And many of the nurses would continue to switch the catheter out until it would work properly.In a 12-hour shift, one patient would need the catheter switched about 3-5 times on average.In general, around 60 -80 percentage of patient were given this catheter experience anything from fecal matter absorbing into the wick, infection from fecal matter spreading to the vagina, and or the catheter moved out of proper position depending on the weight of the patient and it caused a lot of trouble for both the nurses and the patient.Also stated that the purewicks were absorbing urine in a non-invasive way and a light suction would move the urine soaked by the wick into a container.

Manufacturer Narrative

The reported event was confirmed as use related.A potential root cause for this failure could be "patient has fecal incontinence or is menstruating and is unaware of their condition or the restrictions of use." 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.A dhr review was not required because the investigation was confirmed as use related.The instructions for use were found adequate and state the following: "warnings: discontinue use if an allergic reaction occurs.Precautions: having frequent episodes of bowel incontinence without a fecal management system in place".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 user facility had multiple complaints with the purewick female external catheter.And the full success rate of the catheter was only about 25 to 45 percentage.The first issue was many patients experienced diarrhea and leaking stools and soiled with feces, blood and the purewick seems to have an issue with soaking up the fecal matter which would lead to an infection of the vagina if not addressed immediately and cared for.The second issue was the purewick female external catheters were move out of the proper position if the patient was thinner, for example, a 5'6" woman under 145 pounds and subsequently not absorbing the urine properly.And many of the nurses would continue to switch the catheter out until it would work properly.In a 12-hour shift, one patient would need the catheter switched about 3-5 times on average.In general, around 60 -80 percentage of patient were given this catheter experience anything from fecal matter absorbing into the wick, infection from fecal matter spreading to the vagina, and or the catheter moved out of proper position depending on the weight of the patient and it caused a lot of trouble for both the nurses and the patient.Also stated that the purewicks were absorbing urine in a non-invasive way and a light suction would move the urine soaked by the wick into a container.

• Brand Name: UNKNOWN PUREWICK DISPOSABLE
• Type of Device: UNKNOWN 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: 13451148
• MDR Text Key: 285046380
• Report Number: 1018233-2022-00391
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 04/26/2022
• 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: Female