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

Catalog Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problems Pressure Sores (2326); Skin Inflammation/ Irritation (4545)

Event Date 12/20/2022

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 purewick female external catheter broke them out last time, so refused to use.Per additional information received via mail on 29dec2022, it was reported that the patient had developed a stage 2 pressure injury on the sacrococcygeal area.It was stated that the patient had a pure wick catheter which was leaking.It was also stated that the moisture on the skin had put the patient at higher risk of developing pressure injury.The medical intervention status was unknown.

Event Description

It was reported that the purewick female external catheter broke them out last time, so refused to use.Per additional information received via mail on 29dec2022, it was reported that the patient had developed a stage 2 pressure injury on the sacrococcygeal area.It was stated that the patient had a pure wick catheter which was leaking.It was also stated that the moisture on the skin had put the patient at higher risk of developing pressure injury.Medical intervention status was unknown.

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¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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.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: PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: UNKNOWN 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: 16102055
• MDR Text Key: 306694545
• Report Number: 1018233-2023-00007
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• 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): Other
• Patient Sex: Female