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

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.

• 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 Key: 11700532
• MDR Text Key: 246475358
• Report Number: 1018233-2021-02254
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049354
• UDI-Public: (01)00801741049354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Number: 0043610
• Device Catalogue Number: 0043610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 11/04/2021
• Supplement Dates FDA Received: 11/24/2021
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Race: White