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

Device Problem Fluid/Blood Leak (1250)

Patient Problems Itching Sensation (1943); Pain (1994); Burning Sensation (2146); Pressure Sores (2326); Discomfort (2330)

Event Date 01/02/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 : device was not returned.

Event Description

It was reported that on (b)(6) 2023, patient was admitted to (b)(6) hospital after a fall that led to a broken hip requiring surgery.The nurse stated that a purewick female external catheter was in place instead of a foley catheter.On various dates including (b)(6) 2024 they complained of being wet quite often with urine going up the patient's back even with the catheter in place.On (b)(6) 2024 a pressure ulcer was identified on the patient's sacrum.They had complaints of discomfort and pain.Patient was transferred to (b)(6) facility on (b)(6) 2024 and wound care, consulted physician, prescribed ointment daily dressing changes and cleaning with normal saline.Reports of itching and burning with urination.Urinary tract infection was not confirmed.Unknown when purewick female external catheter was discontinued but no longer in use after transfer to (b)(6) facility.

Event Description

It was reported that on (b)(6) 2023, patient was admitted to kings county hospital in brooklyn new york after a fall that led to a broken hip requiring surgery.The nurse stated that a purewick female external catheter was in place instead of a foley catheter.On various dates including (b)(6) 2023 and (b)(6) they complained of being wet quite often with urine going up the patient's back even with the catheter in place.On (b)(6)2024 a pressure ulcer was identified on the patient's sacrum.They had complaints of discomfort and pain.Patient was transferred to mckinney nursing and rehabilitation facility on (b)(6)2024 and wound care, consulted physician, prescribed ointment daily dressing changes and cleaning with normal saline.Reports of itching and burning with urination.Urinary tract infection was not confirmed.Unknown when purewick female external catheter was discontinued but no longer in use after transfer to rehabilitation facility.Per customer follow up received (b)(6)2024, it was reported that the leaking was occurring from the wick and happened every time the customer used the purewick.Customer was no longer using the purewick and was not interested in troubleshooting at this time.

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 and/or improper materials used, assembly collapses under vacuum ¿.The dhr review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.Correction: b,d,h 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 DISPOSABLE
• 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: 18621605
• MDR Text Key: 334311182
• Report Number: 1018233-2024-00379
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/04/2024
• 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