MAUDE Adverse Event Report: PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL; EXTERNAL FEMALE CATHETER

Catalog Number PWF030

Device Problems Suction Problem (2170); Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.The device was not returned.

Event Description

It was reported that a patient experienced two nickel sized purple areas on her labia while using the purewick device.The product was kept in place with mesh under garments.The site is described as a minimal open area with slight bleeding.Gynecologist (gyn) and wound care nurse (woc) were consulted to look at the area.The gyn thought it to be a bruise with maybe a hematoma beneath the surface.The wound care nurse was not sure and will return to have a second look with another set of more experienced eyes.The patient is a slender woman and often holds her legs together.A foley catheter has been placed to monitor output and specific gravity accurately.Per additional information received from the complainant on (b)(6) 2018 via email, barrier cream was applied to the area.The complainant stated that the suction was set at the incorrect suction, although it is unknown what the suction setting was set at.The device had been on the patient for approximately a week.

Event Description

It was reported that a patient allegedly experienced two nickel sized purple areas on her labia while using the purewick device.The product was kept in place with mesh under garments.The site was described as a minimal open area with slight bleeding.Gyn and woc were consulted to look at the area.The gyn thought it to be a bruise with maybe a hematoma beneath the surface.The wound care nurse was not sure and will return to have a second look with another set of more experienced eyes.A foley catheter was placed to monitor output and specific gravity accurately.It was later reported from the complainant on (b)(6)2018 via email that barrier cream was applied to the area.The complainant stated that the suction was set at the incorrect suction no regulator.The device was on the patent approximately a week.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "purewicktm female external catheter instructions for use 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.Indication for use: the purewicktm female external catheter is intended for non-invasive urine output management in female patients.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 with feces or blood.¿ change suction tubing per hospital protocol or at least every thirty (30) days.".

• Brand Name: PUREWICK FEMALE EXTERNAL
• Type of Device: EXTERNAL FEMALE CATHETER
• Manufacturer (Section D): PUREWICK CORPORATION ¿ 3012224959; 203 gillespie way; el cajon CA 92020
• MDR Report Key: 7830397
• MDR Text Key: 118719091
• Report Number: 1018233-2018-03869
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PWF030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other