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

Catalog Number UNKNOWN

Device Problems Fluid/Blood Leak (1250); Increase in Suction (1604)

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 02/03/2021

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 patient was using the purewick while in the hospital for fluid retention.The patient was given diuretics.When patient was using the purewick, the wick was placed on the patient with the tube going over the thigh to the suction on the wall.The patient stated that the purewick machine suction should be 40 as per the tv advertisement, but the hospital had the suction set on 100.At first it worked.When they replaced it on the patient, the catheter leaked urine all over.When the patient put the catheter on again, the patient had so much pain and lot of irritation.The patient had to switch out several times.The patient experienced swelling in that area over a month.No medical intervention reported.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be operator error (mishandling of material or equipment) or equipment failure or malfunction.The dhr review could not be performed without a lot number.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.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.

Event Description

It was reported that the patient was using the purewick while in the hospital for fluid retention.The patient was given diuretics.When patient was using the purewick, the wick was placed on the patient with the tube going over the thigh to the suction on the wall.The patient stated that the purewick machine suction should be 40 as per the tv advertisement, but the hospital had the suction set on 100.At first it worked.When they replaced it on the patient, the catheter leaked urine all over.When the patient put the catheter on again, the patient had so much pain and lot of irritation.The patient had to switch out several times.The patient experienced swelling in that area over a month.No medical intervention reported.

• Brand Name: UNKNOWN PUREWICK DISPOSABLE
• Type of Device: UNKNOWN PUREWICK DISPOSABLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11400385
• MDR Text Key: 238875333
• Report Number: 1018233-2021-00870
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other