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

Model Number	DD15
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
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.
Event or Problem Description
It was reported that the drydoc system smell like fire when it was running then stopped turning on.It was noted that the patient had been using the purewick products for more than 90 days.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be " housing cracks, inadequate design.Improper materials used.Gaps/holes in enclosure allow access for water or other damaging foreign debris, material condition due to selection or degradation (cracks, unintended holes).".It was 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 dhr review could not be performed without a lot number.The instructions for use were found adequate and states the following: 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.Do not place drydoc¿ vacuum station or its cord across walkways creating a tripping hazard.To reduce the risk of electrical shock or injury, do not disassemble this unit.Inspect the drydoc¿ vacuum station periodically for wear.Do not attempt to open or dismantle the drydoc¿ vacuum station.This may affect performance, create a potential safety hazard, cause personal injury and will void the warranty.When the drydoc¿ vacuum station is not in use, unplug power cord from its outlet.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.
Event or Problem Description
It was reported that the drydoc system smell like fire when it was running then stopped turning on.It was noted that the patient had been using the purewick products for more than 90 days.

• Brand Name: DRYDOC VACUUM STATION
• Common Device Name: PUREWICK DRYDOC STATION
• 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: 16183537
• Report Number: 1018233-2023-00123
• Device Sequence Number: 16812298
• Product Code: NZU
• UDI-Device Identifier: 00801741151781
• UDI-Public: (01)00801741151781
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

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 Model Number: DD15
• Device Catalogue Number: DD15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female