MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK ACCESSORIES REPLACEMENT KIT; PUREWICK ACCESSORIES KIT

Model Number PWKIT03

Device Problem Disconnection (1171)

Patient Problem Hematoma (1884)

Event Date 03/23/2022

Event Type  Injury  

Event Description

It was reported that the tubing was coming out of the purewick urine collection system housing.Patient initially stated that both tubes were the same size but later stated that there was a difference.Patient stated the purewick female external catheter was attached to the small tube.Representative advised that the small tube went on the port hole and into motor housing.Representative would assist in proper set up.It was noted that the patient had been using the purewick products for less than 90 days.It was also noted that the purewick accessory kit was replaced on (b)(6) 2022.Per additional information received on 24-mar-2022, the purewick accessory hose came off and attached to the patient's skin and created a hematoma under their breast.The patient had been using this product for less than 90 days.It was unknown what medical intervention was provided for hematoma.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inadequate component (material / dimensions) selection component deterioration ".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "after the purewick¿ urine collection system has been set up, place the purewick¿ external catheter according to the purewick¿ external catheter¿s instructions for use.2.When the canister is ready to be emptied, remove the purewick¿ external catheter according to the purewick¿ external catheter¿s instructions for use and throw away.Note: keep the purewick¿ urine collection system on to make sure all urine has been drawn out of the collector tubing and into the collection canister before removing the purewick¿ external catheter.Note: although the canister can hold up to 2000cc (ml), to prevent overflow empty urine from the collection canister regularly or before volume reaches 1800cc (ml).3.Turn off the purewick¿ urine collection system by pressing the on/off switch.Disconnect the a/c power cord from the power outlet and from the device.Disconnect collector tubing and pump tubing from the canister.4.Lift collection canister from purewick¿ urine collection system.Do not lift canister by the lid.Take canister into an area appropriate for disposal e.G.A bathroom, carefully remove the lid, and dispose of urine in a proper receptacle e.G.A toilet or according to facility protocol.If using a privacy cover and it gets wet, remove and discard.5.Clean collector tubing, pump tubing, canister, purewick¿ urine collection system, and power cord according to cleaning instructions in the cleaning and maintenance section.6.Reassemble the purewick¿ urine collection system according to the initial setup instructions when the system is ready to be reused.When the purewick¿ urine collection system is not in use, unplug the power cord from its outlet.Make sure the unit is cleaned and disinfected prior to storage.Do not store when parts are wet or damp." 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 tubing was coming out of the purewick urine collection system housing.Patient initially stated that both tubes were the same size but later stated that there was a difference.Patient stated the purewick female external catheter was attached to the small tube.Representative advised that the small tube went on the port hole and into motor housing.Representative would assist in proper set up.It was noted that the patient had been using the purewick products for less than 90 days.It was also noted that the purewick accessory kit was replaced on 15-mar-2022.Per additional information received on 24-mar-2022, the purewick accessory hose came off and attached to the patient's skin and created a hematoma under their breast.The patient had been using this product for less than 90 days.It was unknown what medical intervention was provided for hematoma.Per additional information received via liberator on 22apr2022.Stated that the light on the purewick urine collection system was blinking.It was noted that the patient had been using the purewick products for less than 90 days.

• Brand Name: PUREWICK ACCESSORIES REPLACEMENT KIT
• Type of Device: PUREWICK ACCESSORIES KIT
• 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: 14137005
• MDR Text Key: 289454297
• Report Number: 1018233-2022-02660
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741185380
• UDI-Public: (01)00801741185380
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PWKIT03
• Device Catalogue Number: PWKIT03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• 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): Other
• Patient Sex: Female