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

Model Number	PWF030
Medical Device Problem Codes	Increase in Suction (1604); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that the customer had an increase in catheter associated urinary tract infection (cauti¿s), so they were refreshing education on incontinence management without the use of an indwelling catheter.Company representative from some of their other incontinence management products were scheduling times to make brief rounds on inpatient units to refresh knowledge of available products and proper use of the incontinence products.And stated that they had a few incidents of patient harm in the form of bruising in the peri area by using purewick urine collection system.Both times there was significant bruising and there was also noted to be higher amounts of suction 150-200 mmhg.Staff have said that it takes over 100 mmhg to make the urine move through the tubing up to the suction canister.It was unknown what medical intervention was provided for catheter associated urinary tract infection.Per additional information received via email on 13-sep-2022, it was reported that one of the patient experienced bleeding and bruising from the purewick female external catheter and the catheter was taken off and wound nurses saw it.Stated that the patient underwent treatment which was wound, triad or zinc for open areas to buttocks, intradry or miconazole powder for intertriginous dermatitis as stated in order sets.Second patient experienced bruising and no treatment was provided, suction turned down to 40 mmhg.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the customer had an increase in catheter associated urinary tract infection (cauti¿s), so they were refreshing education on incontinence management without the use of an indwelling catheter.Company representative from some of their other incontinence management products were scheduling times to make brief rounds on inpatient units to refresh knowledge of available products and proper use of the incontinence products.And stated that they had a few incidents of patient harm in the form of bruising in the peri area by using purewick urine collection system.Both times there was significant bruising and there was also noted to be higher amounts of suction 150-200 mmhg.Staff have said that it takes over 100 mmhg to make the urine move through the tubing up to the suction canister.It was unknown what medical intervention was provided for catheter associated urinary tract infection.Per additional information received via email on 13-sep-2022, it was reported that one of the patient experienced bleeding and bruising from the purewick female external catheter and the catheter was taken off and wound nurses saw it.Stated that the patient underwent treatment which was wound, triad or zinc for open areas to buttocks, intradry or miconazole powder for intertriginous dermatitis as stated in order sets.Second patient experienced bruising and no treatment was provided, suction turned down to 40 mmhg.
Event or Problem Description
It was reported that the customer had an increase in catheter associated urinary tract infection (cauti¿s), so they were refreshing education on incontinence management without the use of an indwelling catheter.Company representative from some of their other incontinence management products were scheduling times to make brief rounds on inpatient units to refresh knowledge of available products and proper use of the incontinence products.And stated that they had a few incidents of patient harm in the form of bruising in the peri area by using purewick urine collection system.Both times there was significant bruising and there was also noted to be higher amounts of suction 150-200 mmhg.Staff have said that it takes over 100 mmhg to make the urine move through the tubing up to the suction canister.It was unknown what medical intervention was provided for catheter associated urinary tract infection.Per additional information received via email on 13-sep-2022, it was reported that one of the patient experienced bleeding and bruising from the purewick female external catheter and the catheter was taken off and wound nurses saw it.Stated that the patient underwent treatment which was wound, triad or zinc for open areas to buttocks, intradry or miconazole powder for intertriginous dermatitis as stated in order sets.Second patient experienced bruising and no treatment was provided, suction turned down to 40 mmhg.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "user does not follow procedure for establishing suction".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: "setup: 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, connect the canister to the unit and turn the unit on.Please consult the drydoctm vacuum station user guide for further information.Using standard suction tubing, connect the purewicktm female external catheter to the collection canister." 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.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Common Device Name: 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: 15485424
• Report Number: 1018233-2022-07451
• Device Sequence Number: 5224693
• Product Code: NZU
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: PWF030
• Device Catalogue Number: PWF030
• Device Lot Number: MYGN5609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 09/13/2022; 02/07/2023
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 10/06/2022; 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female