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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Localized Skin Lesion (4542)

Event Date 09/17/2021

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 purewick female external catheter leaked and the patient experienced minor lesions on the labia.The patient was treated with bacitracin.Per device application test on (b)(6) 2021, the patient felt sharp discomfort while wearing the device and upon removal.They noted an interior aspect of the device.No further discomfort or bleeding was noted.The patient was given bacitracin to apply.Per follow up information received via phone on 20sep2021, lesions were not healed, and the patient was found to use bacitracin every day, twice a day since (b)(6) 2021.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿dimensions not specified correctly and/or improper materials used assembly collapses under vacuum¿.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the purewick female external catheter product ifus were found to be adequate based on past reviews.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.

Event Description

It was reported that the purewick female external catheter leaked, and the patient experienced minor lesions on the labia.The patient was treated with bacitracin.Per device application test on (b)(6) 2021, the patient felt sharp discomfort while wearing the device and upon removal.They noted an interior aspect of the device.No further discomfort or bleeding was noted.The patient was given bacitracin to apply.Per follow up information received via phone on 20sep2021, lesions were not healed, and the patient was found to use bacitracin every day, twice a day since (b)(6) 2021.

• Brand Name: UNKNOWN PUREWICK DISPOSABLE
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12623474
• MDR Text Key: 276128234
• Report Number: 1018233-2021-06360
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

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: 09/23/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 12/29/2021
• 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