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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2022

Event Type  malfunction  

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 customer had returned the purewick urine collection system and mentioned that the product was not working for the patient.Customer stated that the suction was not strong enough and there was not enough power there to suction the urine.Customer had been using the product for more than 90 days.Per additional information received via liberator on (b)(6) 2022, it was stated that the patient was having motor issue.It was noted that the patient had been using this product more than 90 days.Per additional information received via liberator on (b)(6) 2022, it was stated that the patient had been having trouble on inserting the catheter , had 10 boxes of purewick female external catheter on hand.It was stated that the patient was not able to specify cause of issue and they would see the doctor.The patient had used this product before.

Manufacturer Narrative

The reported issue was confirmed as use related issue as the patient troubled on inserting the catheter.A potential root cause for this failure could be due to ¿user unaware of correct use of device, places device incorrectly".A device history record review was not required as the event was use related.The instructions for use were found adequate and state the following: "never insert the purewicktm female external catheter into vagina, anal canal, or other body cavities.To avoid potential skin injury, never push or pull the purewicktm female external catheter against the skin during placement or removal.Peri-care and placement: 3.Perform perineal care and assess skin integrity (document per hospital protocol).Separate legs, gluteus muscles, and labia.Palpate pubic bone as anatomical marker.4.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.Recommendations: 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.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." 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 customer had returned the purewick urine collection system and mentioned that the product was not working for the patient.Customer stated that the suction was not strong enough and there was not enough power there to suction the urine.Customer had been using the product for more than 90 days.Per additional information received via liberator on 17mar2022, it was stated that the patient was having motor issue.It was noted that the patient had been using this product more than 90 days.Per additional information received via liberator on 05oct2022, it was stated that the patient had been having trouble on inserting the catheter , had 10 boxes of purewick female external catheter on hand.It was stated that the patient was not able to specify cause of issue and they would see the doctor.The patient had used this product before.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15619796
• MDR Text Key: 306603065
• Report Number: 1018233-2022-07900
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 11/22/2022
• 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