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

Device Problem Malposition of Device (2616)

Patient Problem Urinary Tract Infection (2120)

Event Date 06/01/2022

Event Type  Injury  

Event Description

It was reported that the hospital purewick female external catheter caused urinary tract infection.The customer stated that the wick was frequently causing urinary tract infection to them.The representative advised the customer that it sounded like a placement error and the customer agreed because it did not happen at home.It was noted that the patient had been using the products for more than 90 days.It was unknown what medical intervention was provided for urinary tract infection.

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 Description

It was reported that the hospital purewick female external catheter caused urinary tract infection.The customer stated that the wick was frequently causing urinary tract infection to them.The representative advised the customer that it sounded like a placement error and the customer agreed because it did not happen at home.It was noted that the patient had been using the products for more than 90 days.It was unknown what medical intervention was provided for urinary tract infection.

Manufacturer Narrative

The reported event was confirmed use related as event states "placement error".The root cause for this failure could be " user attention failure, places device without adequate access to labia, places device without using pubic bone to align placement, places device incorrectly or is unaware of the proper placement of the device.A dhr review was not required because the investigation was confirmed as use related.The instructions for use were found adequate and state the following: "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.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.Not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter." instruction for use also states " 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 maybe useful for securing the purewicktm female external catheter for some patients." ensure the purewicktm female external catheter remains in the correct position after turning the patient.Remove the purewicktm female external catheter prior to ambulation.Discontinue use if an allergic reaction occurs." 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.H3 other text : the device was not returned.

• Brand Name: UNKNOWN PUREWICK EXTERNAL CATHETER
• Type of Device: UNKNOWN PUREWICK 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: 14744641
• MDR Text Key: 294494085
• Report Number: 1018233-2022-04767
• Device Sequence Number: 1
• Product Code: NZU
• 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: 07/15/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 07/29/2022
• 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