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

Model Number PWFX30

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 11/18/2022

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 customer had still having issues of leakage and irritation with the purewick female external catheter, also had wet the catheter prior to use in order for it to work for better but still having issues.Stated that the leakage was causing problems with other materials getting wet.Customer had to use pads and towels to help, often had to rewash sheets regularly due to leakage.No medical intervention was reported.Per additional information received via form with sample returned on 18nov2022, it was reported that the wick does not conform to the patient body, when patient bent it, it did not stay bent.It was stated that the customer had cut one fourth off of each side of blue cover to ease the rubbing on skin.It was also stated the customer had wet the first one third of wick to help absorb first urine expelled but still it did not catch it all.It was reported that the customer had put double layer of absorbent pads on bed but sometimes it leaked through and did not work as advertised.It was reported patient had a rash, irritation and itching.Medication was given for itching and irritation.

Manufacturer Narrative

The reported event is inconclusive, due to poor sample.1 opened female external catheter (wick) were returned.Sample size = 1.No visual defects were noted on the returned wick.The wick was inspected and found to be assembled correctly, and no foreign matter was observed.Pieces of the blue sleeve were cut off based on inspection.A suction test was done by assembling the returned wick to the in-house accessories and in-house device (serial #(b)(6)).The following value was found sample 1: 500 cc in 20 seconds (pass) the in-house device passed with a value of 2.318 slpm.A potential cause of failure is inadequate material selection - materials of construction are not biocompatible or material surface is rough, abrasive or uncomfortable.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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".Warnings: do not use the purewicktm female external catheter with bedpan or any material that does not allow for sufficient airflow.To avoid potential skin injury, never push or pull the purewicktm female external catheter against the skin during placement or removal.Never insert the purewicktm female external catheter into vagina, anal canal, or other body cavities.Discontinue use if an allergic reaction occurs.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations 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 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 customer had still having issues of leakage and irritation with the purewick female external catheter, also had wet the catheter prior to use in order for it to work for better but still having issues.Stated that the leakage was causing problems with other materials getting wet.Customer had to use pads and towels to help, often had to rewash sheets regularly due to leakage.No medical intervention was reported.Per additional information received via form with sample returned on 18nov2022, it was reported that the wick does not conform to the patient body, when the patient bent it, it did not stay bent.It was stated that the customer had cut one fourth of each side of the blue cover to ease the rubbing on skin.It was also stated the customer had wet the first one third of wick to help absorb the first urine expelled, but still it did not catch it all.It was reported that the customer had put double layer of absorbent pads on bed, but sometimes it leaked through and did not work as advertised.It was reported the patient had a rash, irritation and itching.Medication was given for itching and irritation.Per follow up via phone on 02dec2022, it was reported that the customer was still experienced leak and went to doctor for the reported rash.It was stated that the doctor suggested to use aquaphor on the rash twice a day.Per sample evaluation information received on 30mar2023, the returned sample failed dimensional analysis.

• 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: 15915329
• MDR Text Key: 304799873
• Report Number: 1018233-2022-09243
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2023
• Device Model Number: PWFX30
• Device Catalogue Number: PWFX30
• Device Lot Number: MYFY4229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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 Age: 88 YR
• Patient Sex: Female
• Patient Weight: 84 KG