MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK DRYDOC STATION; DRY DOC

Catalog Number	DD15
Medical Device Problem Code	Increase in Suction (1604)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the patient stated that the wicks have not been working; there has been leaking and spilling issues; in addition they stated sometimes urine was not being collected in container and sometimes it suctions more than other times.The purewick was placed as seen in manual, and there was no blockage or build up in the 70 inch patient hose.A water cup test was conducted and it passed.
Additional Manufacturer Narrative
The reported event was unconfirmed as the problem could not be reproduced.A drydoc device was returned.Inhouse collection jar, patient hose and vacuum hose were used.The device was powered on and the switch illuminated, and the sounds indicative of the pump functioning were present (gross visual evaluation).Evaluation of the sample observed that the pump did function properly.620 ccs of water were suctioned over 20 seconds.A second suction test was ran with identical results.The device met the product specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed as high suction would not likely be caused by the user.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 or Problem Description
It was reported that the patient stated that the wicks have not been working; there has been leaking and spilling issues; in addition they stated sometimes urine was not being collected in container and sometimes it suctions more than other times.The purewick was placed as seen in manual, and there was no blockage or build up in the 70 inch patient hose.A water cup test was conducted and it passed.

• Brand Name: PUREWICK DRYDOC STATION
• Common Device Name: DRY DOC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10017958
• Report Number: 1018233-2020-02960
• Device Sequence Number: 2462252
• Product Code: NZU
• UDI-Device Identifier: 00801741151781
• UDI-Public: (01)00801741151781
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DD15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1