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

Catalog Number PWF030

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

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 customer experienced an uti with use of the device.It was unknown what medical interventions were given for the uti.

Event Description

It was reported that the customer experienced an uti with use of the device.It was unknown what medical interventions were given for the uti.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "inadequate material characteristics, degradation over time".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: ¿caution: this product contains dry natural rubber contraindications: patients with urinary retention warnings: do not use the purewicktm 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 purewicktm female external catheter against the skin during placement or removal.Never insert the purewicktm female external catheter into vagina, 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 purewicktm 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 purewicktm female external catheter.Barrier cream may impede suction.Not recommended for use on patients with a known latex allergy.Proceed with caution in patients who have undergone recent surgery of the external urogenital tract.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter.Maintain suction until the purewicktm female external catheter is fully removed from the patient to avoid urine backflow.Recommendations: perform each step with clean technique.In the home setting, wash hands thoroughly before device placement.Prior to connecting the purewicktm 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 purewicktm female external catheter remains in the correct position after turning the patient.Remove the purewicktm female external catheter prior to ambulation.Properly placing the purewicktm female external catheter snugly between the labia and gluteus holds the purewicktm female external catheter in place for most patients.Mesh underwear may be useful for securing the purewicktm female external catheter for some patients.Assess device placement and patient¿s skin at least every 2 hours.Replace the purewicktm female external catheter every 8-12 hours or when soiled".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.

• Brand Name: PUREWICK FEMALE EXTERNAL
• Type of Device: PUREWICK FEMALE EXTERNAL
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9379142
• MDR Text Key: 168190781
• Report Number: 1018233-2019-07569
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: PWF030
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other