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

Model Number PWFX30

Device Problem Positioning Failure (1158)

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

Event Date 02/17/2023

Event Type  Injury  

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 Description

It was reported that the patient had developed an irritation and a rash from using the purewick female external catheter.Patient said that the catheter would not stay in place and so the ruin got all over the patient¿s bed sheets, clothes and entire body.Patient had been using diaper to try to keep in place and said that the doctor told them not to use and was prescribed with some cream.Stated that they would like a refund and representative advised patient liberator medical service would not accept the return of the product due to the product being opened and used.However, we could accept back the one box of wicks that was not opened or used.It was noted that the patient had been using the purewick products for less than 90 days.

Event Description

It was reported that the patient had developed an irritation and a rash from using the purewick female external catheter.Patient said that the catheter would not stay in place and so the ruin got all over the patient¿s bed sheets, clothes and entire body.Patient had been using diaper to try to keep in place and said that the doctor told them not to use and was prescribed with some cream.Stated that they would like a refund and representative advised patient liberator medical service would not accept the return of the product due to the product being opened and used.However, we could accept back the one box of wicks that was not opened or used.It was noted that the patient had been using the purewick products for less than 90 days.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "dimensions not specified correctly".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: "precautions: not recommended for patients who are: - agitated, combative, or uncooperative and might remove the purewicktm female external catheter.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.- change suction tubing per hospital protocol or at least every thirty (30) days.Peri-care and placement: - 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." 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
• 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: 16520849
• MDR Text Key: 311045121
• Report Number: 1018233-2023-01613
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• 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
• Date Manufacturer Received: 06/17/2023
• 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