MAUDE Adverse Event Report: ADAPTEC MEDICAL DEVICES LLC 3014271001 PUREWICK FEMALE EXTERNAL

Catalog Number PWF030

Device Problems Suction Problem (2170); Suction Failure (4039)

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 wicks do not suction and have caused the customer an uti.It is unknown what medical interventions were given for the uti.

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 were found adequate and state the following: ¿connect the other end of the 70¿ patient tubing securely to purewick¿ fec (h).Caution: it is important that the port connections be connected correctly for proper operation of the drydoc¿ vacuum station." (the letter (h) correlates to a diagram within the ifu.Also found to be adequate as it contains a diagram for connecting the catheter to hospital wall suction.) 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.

Event Description

It was reported that the wicks do not suction and allegedly caused the customer to get an uti.It is unknown what medical interventions were given for the uti.

• Brand Name: PUREWICK FEMALE EXTERNAL
• Type of Device: WICK
• Manufacturer (Section D): ADAPTEC MEDICAL DEVICES LLC 3014271001; 260 james jackson avenue; cary NC 27513
• MDR Report Key: 9523228
• MDR Text Key: 172825857
• Report Number: 1018233-2019-08256
• 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: 02/21/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: PWF030
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other