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

Catalog Number	DD15
Medical Device Problem Code	Increase in Suction (1604)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
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 device had too much suction causing a skin breakdown.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "material surface is rough, abrasive or uncomfortable".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: ¿caution: it is important that the port connections be connected correctly for proper operation of the drydoc¿ vacuum station.Turn on the drydoc¿ vacuum station by pressing the on/off switch on top of the drydoc¿ vacuum station.The drydoc¿ vacuum station is functioning when the switch illuminates and the pump makes a soft humming sound.".
Event or Problem Description
It was reported that the device had too much suction causing a skin breakdown.

• Brand Name: PUREWICK DRYDOC STATION
• Common Device Name: DRYDOC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9157207
• Report Number: 1018233-2019-06230
• Device Sequence Number: 16951558
• Product Code: NZU
• UDI-Device Identifier: 00801741151781
• UDI-Public: (01)00801741151781
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DD15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other