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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN; TROCAR

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C.R. BARD, INC. (COVINGTON) -1018233 CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN; TROCAR Back to Search Results
Model Number 0043610
Device Problem Dull, Blunt (2407)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2021
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 available.
 
Event Description
It was reported that the surgeon was unable to push the trocar through patient's skin as it appeared to be dull while attempting to place the drain in the operative site.
 
Event Description
It was reported that the surgeon was unable to push the trocar through patient's skin as it appeared to be dull while attempting to place the drain in the operative site.
 
Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced / device meets specifications.The reported failure is considered within specification as the reported failure could not be reproduced.The product was used for treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used trocar and channel drain.Visual inspection of the sample noted no obvious visible defects or damage that would cause dullness.The trocar seemed to be sharp without any additional abnormality.No root cause could be found because the reported event was unconfirmed.A dhr review was not required as the investigation was unconfirmed.Therefore, no additional action is required at this time.The device was returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.As the reported event is unconfirmed a labeling review is not required.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 actual/suspected device was inspected.
 
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Brand Name
CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN
Type of Device
TROCAR
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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key11700532
MDR Text Key246475358
Report Number1018233-2021-02254
Device Sequence Number1
Product Code GCY
UDI-Device Identifier00801741049354
UDI-Public(01)00801741049354
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/03/2021
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 Health Professional
Device Model Number0043610
Device Catalogue Number0043610
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/30/2021
Initial Date FDA Received04/21/2021
Supplement Dates Manufacturer Received11/04/2021
Supplement Dates FDA Received11/24/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age74 YR
Patient SexMale
Patient Weight111 KG
Patient RaceWhite
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