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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK DRYDOC STATION; DRY DOC
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C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK DRYDOC STATION; DRY DOC Back to Search Results
Catalog Number DD15
Device Problems Fluid/Blood Leak (1250); Increase in Suction (1604); Defective Device (2588)
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 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.
 
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 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.
 
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Brand Name
PUREWICK DRYDOC STATION
Type of Device
DRY DOC
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10017958
MDR Text Key189880968
Report Number1018233-2020-02960
Device Sequence Number1
Product Code NZU
UDI-Device Identifier00801741151781
UDI-Public(01)00801741151781
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberDD15
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2020
Date Manufacturer Received07/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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