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

Catalog Number	PWF030K
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that patient said she gets a sore from the wicks.It is currently unknown if the patient received medical intervention for the wicks.
Event or Problem Description
It was reported that patient said she gets a sore from the wicks.
Additional Manufacturer Narrative
Upon further review, bard/bd has determined that this mdr was reported in error as this event is not reportable.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 not returned.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure mode could be due to the material surface was rough abrasive or uncomfortable.The device was not returned for evaluation.The lot number was unknown and the information on the packaging lot number was not available therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: contraindications: -patients with urinary retention warnings: -do not use pure wick female external catheter with bedpan or any material that does not allow for sufficient airflow.-to avoid potential skin injury, never push or pull the pure wick female external catheter against the skin during placement or removal, -never insert the pure wick female external catheter into vagina, and anal canal or other body cavities.-discontinue use if an allergic reaction occurs.-after use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.Precautions: -not recommended for patients who are: -agitated, combative or uncooperative and might remove the pure wick female external catheter.-having frequent episodes of bowel incontinence without a fecal management system in place.-experiencing skin irritation or breakdown at the site -experiencing moderate/heavy menstruation and cannot use a tampon.-do not use barrier cream on the perineum when using the pure wick female external catheter.Barrier cream may impede suction -not recommended for use on patients who have undergone recent surgery of the external urogenital tract.-always assess skin for compromise nd perform perineal care prior to placement of a new pure wick female external catheter.-maintain suction until the pure wick female external catheter is fully removed from he patient to avoid urine backflow.Recommendations: -perform each step with clean technique.N the home setting, wash hands thoroughly before device placement.-prior to connecting the pure wick female external catheter to hospital wall suction tubing, verify suction function by covering the open end of the suction tubing with one hand and observing the pressure dial.If the pressure does not increase when the line is covered, verify that the tubing is secured, connected and not kinked.-ensure the pure wick female external catheter remains in the correct position after turning the patient.Remove the pure wick female external catheter prior to ambulation.-properly placing the pure wick female external catheter snugly between the labia and gluteus holds the pure wick female external catheter in place for most patients.Mesh underwear may be useful for securing the pure wick female external catheter for some patients.-assess device placement and patient's skin at least every 2 hours.-replace the pure wick female external catheter every 8-12 hours or when soiled with feces or blood.-change suction tubing per hospital protocol or at least every thirty (30) days.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 not returned.
Event or Problem Description
It was reported that patient said she gets a sore from the wicks.It is currently unknown if the patient received medical intervention for the wicks.

• 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: 10002381
• Report Number: 1018233-2020-02863
• Device Sequence Number: 11459322
• Product Code: NZU
• UDI-Device Identifier: 00801741183614
• UDI-Public: (01)00801741183614
• 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,Followup
• Report Date (Section B): 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: PWF030K
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 05/29/2020; 06/22/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 06/22/2020; 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1