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

Device Problem Increase in Suction (1604)

Patient Problems Bruise/Contusion (1754); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/13/2022

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 customer had an increase in catheter associated urinary tract infection (cauti¿s), so they were refreshing education on incontinence management without the use of an indwelling catheter.Company representative from some of their other incontinence management products were scheduling times to make brief rounds on inpatient units to refresh knowledge of available products and proper use of the incontinence products.And stated that they had a few incidents of patient harm in the form of bruising in the peri area by using purewick urine collection system.Both times there was significant bruising and there was also noted to be higher amounts of suction 150-200 mmhg.Staff have said that it takes over 100 mmhg to make the urine move through the tubing up to the suction canister.It was unknown what medical intervention was provided for catheter associated urinary tract infection.As per additional information received via email on 13sep2022, it was reported that one of the patient experienced bleeding and bruising from the purewick female external catheter and the catheter was taken off and wound nurses saw it.Stated that the patient underwent treatment which was wound, triad or zinc for open areas to buttocks, intradry or miconazole powder for intertriginous dermatitis as stated in order sets.Second patient experienced bruising and no treatment was provided, suction turned down to 40 mmhg.

Event Description

It was reported that the customer had an increase in catheter associated urinary tract infection (cauti¿s), so they were refreshing education on incontinence management without the use of an indwelling catheter.Company representative from some of their other incontinence management products were scheduling times to make brief rounds on inpatient units to refresh knowledge of available products and proper use of the incontinence products.And stated that they had a few incidents of patient harm in the form of bruising in the peri area by using purewick urine collection system.Both times there was significant bruising and there was also noted to be higher amounts of suction 150-200 mmhg.Staff have said that it takes over 100 mmhg to make the urine move through the tubing up to the suction canister.It was unknown what medical intervention was provided for catheter associated urinary tract infection.As per additional information received via email on (b)(6)2022, it was reported that one of the patient experienced bleeding and bruising from the purewick female external catheter and the catheter was taken off and wound nurses saw it.Stated that the patient underwent treatment which was wound, triad or zinc for open areas to buttocks, intradry or miconazole powder for intertriginous dermatitis as stated in order sets.Second patient experienced bruising and no treatment was provided, suction turned down to 40 mmhg.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to "dimensions not specified correctly".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore, bd was unable to determine the associated labeling to review.Correction: e h11: section a through f - 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.H3 other text : the device was not returned.

• Brand Name: UNKNOWN PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: UNKNOWN PUREWICK FEMALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15527457
• MDR Text Key: 301013399
• Report Number: 1018233-2022-07601
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female