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

Model Number PWF030F

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Reaction (2414)

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 patient had a bad reaction that resulted in an infection and also stated that there was latex involved in the product.Patient is now in hospice.It is unknown what medical intervention was provided for the infection.

Event Description

It was reported that the patient had a bad reaction that resulted in an infection and also stated that there was latex involved in the product.The patient was now in hospice.It is unknown what medical intervention was provided for the infection.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to the material surface is rough, abrasive or uncomfortable.The device was not returned for evaluation.The lot number was unknown and the information on the manufacturing 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: "indication for use: the purewicktm female external catheter is intended for non-invasive urine output management in female patients.Contraindications: -patients with urinary retention warnings: -do not use purewick 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 purewick female external catheter against the skin during placement or removal, -never insert the purewick 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 purewick 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 purewick 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 purewick female external catheter.-maintain suction until the purewick 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 purewick 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 purewick female external catheter remains in the correct position after turning the patient.Remove the purewick female external catheter prior to ambulation.-properly placing the purewick female external catheter snugly between the labia and gluteus holds the purewick female external catheter in place for most patients.Mesh underwear may be useful for securing the purewick female external catheter for some patients.-assess device placement and patient's skin at least every 2 hours.-replace the purewick 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.Setup: 1.Connect the canister to wall suction and set to a minimum of 40mmhg continuous suction.Always use the minimum amount of suction necessary.If using the drydoctm vacuum station, connect the canister to the unit and turn the unit on.Please consult the drydoctm vacuum station user guide for further information.2.Using standard suction tubing, connect the purewicktm female external catheter to the collection canister.Peri-care and placement: 3.Perform perineal care and assess skin integrity (document per hospital protocol).Separate legs, gluteus muscles, and labia.Palpate pubic bone as anatomical marker.4.With soft gauze side facing patient, align distal end of the purewicktm female external catheter at gluteal cleft.Gently tuck soft gauze side between separated gluteus and labia.Ensure that the top of the gauze is aligned with the pubic bone.Slowly place legs back together once the purewicktm female external catheter is positioned.Note: patient can be positioned on back, side lying, frog legged, or lying on back with knees bent and thighs apart (lithotomy position) prior to device placement.Removal: 5.To remove the purewicktm female external catheter, fully separate the legs, gluteus, and labia.To avoid potential skin injury upon removal, gently pull the purewicktm female external catheter directly outward.Ensure suction is maintained while removing the purewicktm female external catheter.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.Maintenance: 6.Replace the purewicktm female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter." 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 CATHETER
• Type of Device: PUREWICK FEMALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10308926
• MDR Text Key: 199900595
• Report Number: 1018233-2020-04700
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741163081
• UDI-Public: (01)00801741163081
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PWF030F
• Device Catalogue Number: PWF030F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other