MAUDE Adverse Event Report: INTEGRA YORK, PA INC. CARB-BITE CRILE-WOOD NH 6; CARDIOVASCULAR NEEDLE HOLDERS

Catalog Number 121130

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

It was reported by an administrative and logistic manager that on (b)(6) 2018, a carb-bite crile-wood was used in a procedure.However, it was noticed that the product was broken inside the patient's body.No further patient injury were reported and no delay in the procedure.Additional information has been requested.

Manufacturer Narrative

The product was not returned for evaluation; therefore, the failure analysis could not be performed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.

• Brand Name: CARB-BITE CRILE-WOOD NH 6
• Type of Device: CARDIOVASCULAR NEEDLE HOLDERS
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 7298026
• MDR Text Key: 100998817
• Report Number: 2523190-2018-00028
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121130
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 02/23/2018
• Supplement Dates FDA Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 MO