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

Catalog Number PWF030

Device Problems Suction Problem (2170); Biocompatibility (2886)

Patient Problems Skin Irritation (2076); No Known Impact Or Consequence To Patient (2692)

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 the nurses in the hospital did not know the proper suction and it gave her a wound.No medical intervention was reported.

Event Description

It was reported the nurses in the hospital did not know the proper suction and it gave her a wound.No medical intervention was reported.Per follow up call on 24appr2020, the patient was not willing to provide additional information at the time and noted that they are waiting to speak with the doctor.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to ¿inadequate material selection - materials of construction are not biocompatible¿ or the user did not follow procedure for establishing suction".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: "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".It also states the catheter is "not recommended for use on patients with a known latex allergy".These instructions would help prevent potential use related causes of the reported issue.The ifu also states "connect the canister to wall suction and set to a minimum of 40mmhg continuous suction.Always use the minimum amount of suction necessary." 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.

Event Description

It was reported the nurses in the hospital did not know the proper suction and it gave her a wound.No medical intervention was reported.Per follow up on 24apr2020, the patient was not willing to provide additional information at the time and noted that they are waiting to speak with the doctor.

• Brand Name: PUREWICK FEMALE EXTERNAL
• Type of Device: PUREWICK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9975699
• MDR Text Key: 188476619
• Report Number: 1018233-2020-02677
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741151781
• UDI-Public: (01)00801741151781
• 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,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2020
• 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
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other