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

Catalog Number PWF030

Device Problems Fluid/Blood Leak (1250); Increase in Suction (1604)

Patient Problems Edema (1820); Patient Problem/Medical Problem (2688)

Event Date 08/11/2018

Event Type  malfunction  

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 while doing perineal care on a patient, the patient had an impression of the catheter in her perineal area, and the area did not blanch for in less than 3 seconds.No skin breakdowns were noted.The external catheter was discontinued and replaced with an indwelling foley catheter.The patient was post stemi and cardiogenic shock requiring levophed, bumex, iabp, and stents.The patient had generalized edema in the lower extremities including the perineum, which was "severely edematous".An indwelling foley catheter was discontinued and replaced with an external female catheter to catch incontinent urine.The external catheter caught approximately 50% of the patient's urine.Due to incontinence and leaking around the external catheter, frequent peri-care was being performed.Per additional information received from the complainant via email on (b)(6) 2018: the setting of the suction is unknown.The area was not treated with anything.The patient had pre-existing edema including in the area of her perineum.

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿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 purewick® 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 purewick® 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 purewick® 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.Maintenance: removal: 5.To remove the purewick® female external catheter, fully separate the legs, gluteus, and labia.To avoid potential skin injury upon removal, gently pull the purewick® female external catheter directly outward.Ensure suction is maintained while removing the purewick® 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.6.Replace the purewick® 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 purewick® female external catheter.Indication for use: the purewick® 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 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, 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 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 purewick® female external catheter.¿ maintain suction until the purewick® 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 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.".

Event Description

It was reported that while doing perineal care on a patient, the patient had an impression of the catheter in her perineal area, and the area did not blanch for in less than 3 seconds.No skin breakdowns were noted.The external catheter was discontinued and replaced with an indwelling foley catheter.The patient was post stemi and cardiogenic shock requiring levophed, bumex, iabp, and stents.The patient had generalized edema in the lower extremities including the perineum, which was "severely edematous".An indwelling foley catheter was discontinued and replaced with an external female catheter to catch incontinent urine.The external catheter caught approximately 50% of the patient's urine.Due to incontinence and leaking around the external catheter, frequent peri-care was being performed.Per additional information received from the complainant via email on (b)(6)2018: the setting of the suction is unknown.The area was not treated with anything.The patient had pre-existing edema including in the area of her perineum.

• Brand Name: PUREWICK FEMALE EXTERNAL.
• Type of Device: FEMALE EXTERNAL CATHETER
• Manufacturer (Section D): PUREWICK CORPORATION ¿ 3012224959; 203 gillespie way; el cajon CA 92020
• MDR Report Key: 7888996
• MDR Text Key: 121462912
• Report Number: 1018233-2018-04243
• 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: other
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Catalogue Number: PWF030
• Device Lot Number: MYCRWF31
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 60