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

Catalog Number DD15

Device Problems Labelling, Instructions for Use or Training Problem (1318); Component Missing (2306)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

It was reported that the patient did not receive a manual with the purewick drydoc system.

Event Description

It was reported that the patient did not receive a manual with the purewick drydoc system.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.The potential root cause could be due to " operator error -incorrect packaging".The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not completed as the user would not likely cause this issue.

• Brand Name: PUREWICK DRYDOCK STATION
• Type of Device: PUREWICK DRYDOC STATION
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9684065
• MDR Text Key: 183915624
• Report Number: 1018233-2020-00881
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741151781
• UDI-Public: (01)00801741151781
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: DD15
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 03/13/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1