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

Catalog Number PWFX30

Device Problem Decrease in Suction (1146)

Patient Problems Bacterial Infection (1735); Sepsis (2067); Urinary Tract Infection (2120)

Event Date 08/15/2023

Event Type  Injury  

Event Description

It was reported that the patient was no longer using because the wick was backing up and not suctioning properly and caused the patient to develop multiple bacterial infections.It was unknown what medical intervention was provided for bacterial infections.Per follow up via phone on 22 aug 2023, customer experienced a sepsis infection and an urinary tract infection with used.Customer was treated at the emergency room for the sepsis infection and then treated with antibiotics for the urinary tract infection.Customer's husband stated that the customer has multiple sclerosis which caused them body to spasm.

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.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be due to "dimensions not specified correctly and/or improper materials used assembly collapses under vacuum".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.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: ¿setup: 1.Connect the canister to wall suction and set to a minimum of 40mmhg continuous suction.Always use the minimum amount of suction necessary.If using the drydoctm vacuum station / purewick¿ urine collection system, connect the canister to the unit and turn the unit on.Please consult the purewick¿ urine collection system user guide for further information.2.Using standard suction tubing, connect the purewick¿ female external catheter to the collection canister.Precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter.Peri-care and placement: 1.Perform perineal care and assess skin integrity (document per hospital protocol).Separate legs, gluteus muscles, and labia.Palpate pubic bone as anatomical marker.2.With soft gauze side facing patient, align distal end of the purewicktm female external catheter at gluteal cleft.Gently tuck soft gauze side between separated gluteus and labia.Ensure that the top of the gauze is aligned with the pubic bone.Slowly place legs back together once the purewicktm female external catheter is positioned.Note: patient can be positioned on back, side lying, frog legged, or lying on back with knees bent and thighs apart (lithotomy position) prior to device placement.Recommendations: ensure the purewicktm female external catheter remains in the correct position after turning the patient.Remove the purewicktm female external catheter prior to ambulation.Properly placing the purewicktm female external catheter snugly between the labia and gluteus holds the purewicktm female external catheter in place for most patients.Mesh underwear maybe useful for securing the purewicktm female external catheter for some patients.Change suction tubing per hospital protocol or at least every thirty (30) days.Do not use barrier cream on the perineum when using the purewicktm female external catheter.Barrier cream may impede suction.Do not use the purewicktm female external catheter with bedpan or any material that does not allow for sufficient airflow".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 the patient was no longer using because the wick was backing up and not suctioning properly and caused the patient to develop multiple bacterial infections.It was unknown what medical intervention was provided for bacterial infections.Per follow up via phone on 22aug2023, customer experienced a sepsis infection and an urinary tract infection with used.Customer was treated at the emergency room for the sepsis infection and then treated with antibiotics for the urinary tract infection.Customer's husband stated that the customer has multiple sclerosis which caused them body to spasm.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17728278
• MDR Text Key: 323161973
• Report Number: 1018233-2023-06703
• 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: 09/25/2023

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: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 09/27/2023
• 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): Required Intervention
• Patient Sex: Female