MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DRY DOC MACHINE

Catalog Number	DD15
Medical Device Problem Code	Misassembled (1398)
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 said there was a wire with a red cap exposed on the back of the drydoc.Per follow up with customer on (b)(6) 2020, they stated the device would not power on.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause could be due to "loose connection in strain relief".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: ¿¿ always unplug drydoc¿ vacuum station when not in use.¿ do not immerse in water.As with most electrical devices, electrical parts in this system are electrically live even when the power is off.To reduce risk of electric shock, if the drydoc¿ vacuum station falls into water, unplug immediately.Do not reach into water.¿ if drydoc¿ vacuum station is dropped or tipped over spilling urine, unplug the unit and thoroughly inspect for loose or damaged parts before resuming use.Contact customer support at 1-888-201-1586 if damage is observed.¿ the 16¿ vacuum tubing connecting drydoc¿ vacuum station to collection canister may experience light condensation.This is not unusual and does not affect function.However, if urine or water has streamed into the pump, discontinue use and contact customer support at 1-888-201-1586.Some indications that water or urine has streamed into the pump are fluid or stains observed on the bottom exterior of device.¿ empty urine from collection canister regularly to prevent overflow.Failure to empty canister before urine overflow may cause damage to drydoc¿ vacuum station and is not covered under warranty.¿ it is important that the port connections be connected correctly for proper operation of the drydoc¿ vacuum station.¿ do not place drydoc¿ vacuum station or its cord across walkways creating a tripping hazard.".
Event or Problem Description
It was reported that the patient said there was a wire with a red cap exposed on the back of the drydoc.Per follow up with customer on 28jan2020, they stated the device would not power on.

• Brand Name: DRY DOC MACHINE
• Common Device Name: DRY DOC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9729653
• Report Number: 1018233-2020-01174
• Device Sequence Number: 727442
• 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): 03/24/2020

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?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1