MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM

Catalog Number PW200

Device Problem Suction Failure (4039)

Patient Problem Rash (2033)

Event Date 08/02/2023

Event Type  Injury  

Event Description

It was reported that the purewick urine collection system had not worked from the start.Per additional information received via liberator on 02aug2023, patient stated purewick urine collection system not working since they started using.It was stated that the patient had rash on buttocks after start of used, also stated the patient was in chemotherapy.The patient went to emergency room to treat rash.The representative advised the patient trouble shooting was needed to make a warranty determination.The patient stated already did that and was not going through it again, and was a breast cancer the patient, did not have time for this.Per additional information received via liberator on 10aug2023, patient stated purewick urine collection system had no suction.The representative did water test the machine failed and sending new kit.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be " inadequate system design (not designed for intended use, expected service life or operating conditions or transport and storage conditions)".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.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: ¿place the collection canister (c) in the purewick¿ urine collection system base and press down firmly on the lid making sure the lid is sealed.Optional (prior to sealing canister lid): while operating the purewick¿ urine collection system, ammonia odor for up to 1800 ml of urine can be eliminated by adding 2 teaspoons (10 grams) of vitamin c (ascorbic acid) powder into the collection canister before use.At least 99.93% of pure vitamin c (ascorbic acid) is recommended.If using the privacy cover (j), slip privacy cover onto canister (similar to a coffee cup sleeve) prior to placing canister into the base.Attach the pump tubing (d) to the purewick¿ urine collection system connector port (f) and the connector port (e) on the collection canister lid.Attach the collector tubing (g) to the connector port (h) on the collection canister lid.Connect the other end of the collector tubing securely to a purewick¿ external catheter (i).[note the letters correlate to a diagram within the ifu].Caution: it is important that the port connections be connected correctly and securely for proper operation of the purewick¿ urine collection system.The device is on but is not suctioning properly: 1.Ensure tubing connections are connected properly.2.Check collector tubing for blockage or flow restriction such as pinched or kinked tubing.3.Ensure overflow stop valve in collection canister lid is open.The valve floats to the top when the collection canister is full.The stop valve may close if the lid or canister is tipped sideways or upside down.Disconnect tubing and gently shake the lid to reset the valve down to the open position.4.Ensure collection canister is sealed with the lid tightly closed.5.Verify suction by disconnecting purewick¿ external catheter from the collector tubing and placing the end of the collector tubing into a cup of water.If water easily flows into the collection canister replace the purewick¿ external catheter".H11: section a through f - the information provided by bd represents all 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.

• Brand Name: PUREWICK URINE COLLECTION SYSTEM
• Type of Device: PUREWICK URINE COLLECTION SYSTEM
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17651136
• MDR Text Key: 322291830
• Report Number: 1018233-2023-06303
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741185359
• UDI-Public: (01)00801741185359
• 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
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: PW200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female