MAUDE Adverse Event Report: AV-TEMECULA-CT PLUS 30 PRIORITY PACK ACCESSORY KIT; ACCESSORIES

Catalog Number	1000185
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: it was reported that an expired plus 30 priority pack device was sent to the customer.The indeflator was returned inside the unopened chipboard box and unopened tray.The expiration dates on the chipboard box and tray labels were 2018-01-31, confirming the reported issue.The complaint investigation determined the product had been shipped with an incorrect expiration date.On (b)(6) 2018, abbott vascular decided to initiate a voluntary field action for this product.Abbott vascular submitted medwatch # 2024168-2018-05114 on june 28, 2018 with notification of the voluntary recall, (remedial action initiated).Corrective action has been implemented per site operating procedures.The product will continue to be trended.The additional 87 priority pack (ppak) devices referenced are being filed under separate medwatch report numbers.
Event or Problem Description
It was reported that 88 expired units of ppak devices were sent to the account.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.

• Brand Name: PLUS 30 PRIORITY PACK ACCESSORY KIT
• Common Device Name: ACCESSORIES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7684174
• Report Number: 2024168-2018-05414
• Device Sequence Number: 11112298
• Product Code: MAV
• UDI-Device Identifier: 08717648013607
• UDI-Public: 08717648013607
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K896849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 1000185
• Device Lot Number: 60047593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1