MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION GRAFTS ACCESSORIES TUNNELERS; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number 26026

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

On receipt of product it was noted that the #6 and #8 bullet tips were missing.

Manufacturer Narrative

Analysis: as the device in question was not returned atrium medical corporation cannot confirm that there were any tunneler rod tips missing from the tunneler rod kit.There was also no lot number provided with the complaint.If the lot number had been provided the device history records would have been reviewed to ensure that the correct amount of tips was issued to the manufacturing work order prior to manufacturing.The records would also have been reviewed to ensure all parts were used and not scrapped during the process of manufacture.Due to the lot number not being supplied a tunneler rod kit of the same p/n 26026 was obtained from inventory to ensure all tips were accounted for.The review of the materials indicated that all components were accounted for.Conclusion: as the product was not returned and the product lot number in question not provided atrium medical corporation cannot confirm that there were tips missing from the supplied kit to the institution.There has been no other reported complaint regarding missing tunneler tips.H3 other text : product not returned.

• Brand Name: GRAFTS ACCESSORIES TUNNELERS
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9437437
• MDR Text Key: 190342312
• Report Number: 3011175548-2019-01218
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00650862260267
• UDI-Public: 00650862260267
• Combination Product (y/n): N
• PMA/PMN Number: D120332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26026
• Device Catalogue Number: 26026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other