MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM STND (NON-BATTERY); UNKNOWN PUREWICK URINE COLLECTION SYSTEM

Device Problems No Apparent Adverse Event (3189); Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the staff had added extension tubing to the purewick to allow for patient to move easier in bed who developed the deep tissue injuries, but it was not working.Then the suction was turned up to 80.Also stated that customer don't see any recommendations in guidelines to see if use of extension tubing was okay or not.Medical intervention was unknown.Per follow up received on 11jun2021,customer stated that the unit had been in use for about 48 hours and patient was obese, the deep tissue injuries at discharge was still superficial only requiring use of barrier cream.Patient was discharged 24 hours after injury so unsure if worsened post discharge.The tubing used was a second set of suction tubing with the provided plastic connection, suction setting was 80 but usual setting in house has been 40-60 mmhg.Customer were in the process of tweaking their policy to include how to adjust suction for use with extension tubing, and were addressing maintenance care with nurse in question.Per follow up received on 17jun2021, customer stated that patient's skin was documented within normal limits on admission and was developed during use of purewick.

Manufacturer Narrative

Per investigator evaluation, bd has determined that this mdr event is not reportable.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.

Event Description

It was reported that that the staff had added extension tubing to the purewick to allow for patient to move easier in bed who developed the deep tissue injuries, but it was not working.Then the suction was turned up to 80.Also stated that customer don't see any recommendations in guidelines to see if use of extension tubing was okay or not.Medical intervention was unknown.Per follow up received on (b)(6) 2021,customer stated that the unit had been in use for about 48 hours and patient was obese, the deep tissue injuries at discharge was still superficial only requiring use of barrier cream.Patient was discharged 24 hours after injury so unsure if worsened post discharge.The tubing used was a second set of suction tubing with the provided plastic connection, suction setting was 80 but usual setting in house has been 40-60 mmhg.Customer were in the process of tweaking their policy to include how to adjust suction for use with extension tubing, and were addressing maintenance care with nurse in question.Per follow up received on (b)(6) 2021, customer stated that patient's skin was documented within normal limits on admission and was developed during use of purewick.

• Brand Name: PUREWICK URINE COLLECTION SYSTEM STND (NON-BATTERY)
• Type of Device: UNKNOWN PUREWICK URINE COLLECTION SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12044473
• MDR Text Key: 257569144
• Report Number: 1018233-2021-03710
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other