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

Catalog Number	PWF030
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/03/2017
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 a patient developed a "friction abrasion on the buttock area".The wound ostomy nurse (won) described the abrasions as resembling "suction marks".It was discovered that the device had not been properly placed and the suction was at 200 mmhg.It was unknown when the device was last changed.Immediately following the event, the female external catheter was discontinued.It was replaced the following day after the staff had additional training on the device.The won stated that after two days of the area being treated with an over the counter skin barrier cream, the area in question was almost healed.It was confirmed that the patient was not on a bedpan.The won stated that this was user error and has scheduled additional training with all the staff on the use of this device.The patient was placed on the device on (b)(6) 2017 for 10 days.The history of the patient includes that she is a larger patient, in a vegetative state, and has been in the care of the facility for over a year.Clinical statement: the ifu states to "always use the minimum amount of suction necessary." regarding placement of the device, the ifu instructs to "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 device is positioned.This is to be done after perineal care has been performed.The ifu states that the device should be changed "at least every 8-12 hours.".
Additional 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: "setup: 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 drydoc vacuum station, connect the canister to the unit and turn the unit on.Please consult the drydoc vacuum station user guide for further information.Using standard suction tubing, connect the purewick female external catheter to the collection canister.Peri-care and placement: perform perineal care and assess skin integrity (document per hospital protocol).Separate legs, gluteus muscles, and labia.Palpate pubic bone as anatomical marker.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.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." (b)(4).
Event or Problem Description
It was reported that a patient developed a "friction abrasion on the buttock area".The wound ostomy nurse (won) described the abrasions as resembling "suction marks".It was discovered that the device had not been properly placed and the suction was at 200 mmhg.It was unknown when the device was last changed.Immediately following the event, the female external catheter was discontinued.It was replaced the following day after the staff had additional training on the device.The won stated that after two days of the area being treated with an over the counter skin barrier cream, the area in question was almost healed.It was confirmed that the patient was not on a bedpan.The won stated that this was user error and has scheduled additional training with all the staff on the use of this device.The patient was placed on the device on (b)(6) 2017 for 10 days.The history of the patient includes that she is a larger patient, in a vegetative state, and has been in the care of the facility for over a year.Clinical statement: the ifu states to "always use the minimum amount of suction necessary." regarding placement of the device, the ifu instructs to "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 device is positioned.This is to be done after perineal care has been performed.The ifu states that the device should be changed "at least every 8-12 hours." tschlager (b)(6) 2017.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Common Device Name: FEMALE EXTERNAL CATHETER
• Manufacturer (Section D): PUREWICK CORPORATION ¿ 3012224959; 203 gillespie way; el cajon CA 92020
• MDR Report Key: 6982581
• Report Number: 1018233-2017-05510
• Device Sequence Number: 1222681
• Product Code: NNW
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2017

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: Health Professional
• Device Catalogue Number: PWF030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other