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

Model Number 0043610

Device Problem Dull, Blunt (2407)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported the surgeon was attempting to make the "stab wound" to place the drain and encountered a dull tip.A scalpel was needed to pierce the skin and place the drain.The patient surgery was a cervical laminectomy of c3-c7.

Event Description

It was reported that the surgeon was attempting to make the stab wound to place the drain and encountered a dull tip.A scalpel was needed to pierce the skin and place the drain.The patient surgery was a cervical laminectomy c3 to c7.

Manufacturer Narrative

The reported event was unconfirmed as the product meet the specifications.Visual inspection noted one opened 3 spring evacuator was received with the original package.Visual evaluation noted no obvious defects.The trocar appeared to be very sharp with no abnormalities.The product was used for the treatment purposes.It was determined that the product had no relationship with the event due to the investigation being unconfirmed through the sample evaluation.The product had met specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the labeling could not have prevented the reported failure.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.H3 other text : the actual/suspected device was inspected.

• Brand Name: CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN
• Type of Device: CLOSED WOUND SUCTION KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11344078
• MDR Text Key: 232412898
• Report Number: 1018233-2021-00630
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049354
• UDI-Public: (01)00801741049354
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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
• Device Lot Number: NGEQ3533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 79