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

Catalog Number	PWF030
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was returned.
Event or Problem Description
It was reported that the pure wick in the hospital caused the patient to develop an e.Coli/uti infection.The pure wick reportedly damaged the patients vaginal skin.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause could be due to "material surface is rough, abrasive or uncomfortable" and/or "materials of construction are not biocompatible".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿to avoid potential skin injury upon removal, gently pull the purewick female external catheter directly outward" and "to avoid potential skin injury, never push or pull the purewick female external catheter against the skin during placement or removal".H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was returned.
Event or Problem Description
It was reported that the pure wick in the hospital caused the patient to develop an e.Coli/uti infection.The pure wick reportedly damaged the patients vaginal skin.

• Brand Name: PUREWICK FEMALE EXTERNAL
• Common Device Name: PUREWICK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9769985
• Report Number: 1018233-2020-01427
• Device Sequence Number: 3308165
• Product Code: NZU
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: PWF030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other