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

Model Number PWFX30

Device Problem Malposition of Device (2616)

Patient Problem Urinary Tract Infection (2120)

Event Date 12/21/2021

Event Type  Injury  

Event Description

It was reported that the patient believed that the hoses they received in the purewick accessories replacement kit were defective and no specifics were given.Per follow up on 21may2021, the tubing was too loose and did not stay on tightly.Per sample received notification on 03sep2021, purewick urine collection system was returned for evaluation and exact defect was unknown.Per customer via phone on 13dec2021, it was stated that the returned machine had only one problem and it was with the power cord not staying connected no matter how hard it was pushed into the system.Customer had same power cord problem with the currently using machine.Per customer via phone on (b)(6) 2021, caller reiterated the problem with the power cord but did not provide machine reference or serial number.And patient was no longer using the system due to five repeated urinary tract infections and patient was hospitalized each time for iv antibiotics.Also, caller was concerned that the catheter went too far down and may be got bowel on the tip.And patient was not sure if the caregiver was careful enough to not accidentally spread the bowel when removing the catheter.Caller suggested that something was needed to be created to go over the end of the catheter that would come off and stay in the diaper while removing the catheter it would protect the catheter from contamination.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the patient believed that the hoses they received in the purewick accessories replacement kit were defective and no specifics were given.Per follow up on (b)(6) 2021, the tubing was too loose and did not stay on tightly.Per sample received notification on 03sep2021, purewick urine collection system was returned for evaluation and exact defect was unknown.Per customer via phone on 13dec2021, it was stated that the returned machine had only one problem and it was with the power cord not staying connected no matter how hard it was pushed into the system.Customer had same power cord problem with the currently using machine.Per customer via phone on (b)(6) 2021, caller reiterated the problem with the power cord but did not provide machine reference or serial number.And patient was no longer using the system due to five repeated urinary tract infections and patient was hospitalized each time for iv antibiotics.Also, caller was concerned that the catheter went too far down and may be got bowel on the tip.And patient was not sure if the caregiver was careful enough to not accidentally spread the bowel when removing the catheter.Caller suggested that something was needed to be created to go over the end of the catheter that would come off and stay in the diaper while removing the catheter it would protect the catheter from contamination.

Event Description

It was reported that the patient believed that the hoses they received in the purewick accessories replacement kit were defective and no specifics were given.Per follow up on (b)(6) 2021, the tubing was too loose and did not stay on tightly.Per sample received notification on (b)(6) 2021, purewick urine collection system was returned for evaluation and exact defect was unknown.Per customer via phone on (b)(6) 2021, it was stated that the returned machine had only one problem and it was with the power cord not staying connected no matter how hard it was pushed into the system.Customer had same power cord problem with the currently using machine.Per customer via phone on 21dec2021, caller reiterated the problem with the power cord but did not provide machine reference or serial number.And patient was no longer using the system due to five repeated urinary tract infections and patient was hospitalized each time for iv antibiotics.Also, caller was concerned that the catheter went too far down and may be got bowel on the tip.And patient was not sure if the caregiver was careful enough to not accidentally spread the bowel when removing the catheter.Caller suggested that something was needed to be created to go over the end of the catheter that would come off and stay in the diaper while removing the catheter it would protect the catheter from contamination.

Manufacturer Narrative

The reported event is confirmed use related.The failure was caused by the misuse of the product.The potential root cause for the issue could be "user attention failure, places device incorrectly or is unaware of the proper placement of the device.".The device history record review was not required as the reported event was use related.The instructions for use were found adequate and state the following: "perform perineal care and assess skin integrity (document per hospital protocol).Separate legs, gluteus muscles, and labia.Palpate pubic bone as anatomical marker.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 may be useful for securing the purewicktm female external catheter for some patients.'' 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.The device was not returned.

• 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: 13129494
• MDR Text Key: 285567741
• Report Number: 1018233-2021-08660
• 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: 02/23/2022

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: 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: 12/21/2021
• Initial Date FDA Received: 12/31/2021
• Supplement Dates Manufacturer Received: 02/23/2022
• Supplement Dates FDA Received: 03/18/2022
• 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): Required Intervention
• Patient Sex: Female