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

Catalog Number 121197

Device Problems Device Reprocessing Problem (1091); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports they received package with dried blood on the instrument and also inside the box.On (b)(6) 2015 customer (dealer) reports product not delivered to healthcare customer.There was no blood inside on the box.The customer reports not sure it was blood, it was a brown color and it was in the box lock of the instruments.Instruments were in plastic delivery bags.

Manufacturer Narrative

11/11/15 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - three needle holders were received in unused condition in the original package, not showing any unusual markings.Upon visually inspecting the instruments, it is noticed that there is staining at the hinges.A 1.5% aql sampling of existing inventory was performed.There was no nonconformance¿s found in inventory for this item.The complaint report is confirmed and scar was issued for this nonconformity, also one instrument was sent for lab analysis and the other two was sent to (b)(4).Device history evaluation - dhr review was completed with all history available.Nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: the complaint report has been confirmed; the root cause has been identified as a workmanship or material deficiency.Appropriate action has been implemented to rectify this manufacturing deficiency.

• Brand Name: CARB-BITE PETIT-SAROT NH 6
• Type of Device: CARDIOVASCULAR NEEDLE HOLDERS
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5169673
• MDR Text Key: 29008113
• Report Number: 2523190-2015-00109
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 121197
• Device Lot Number: 5218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1