MAUDE Adverse Event Report: ABBOTT VASCULAR 20/30 PRIORITY PACK INDEFLATOR; ACCESSORIES

Model Number 1000184

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that during use of a 20/30 indeflator there was difficulty inflating the unspecified device.There were no adverse patient effects reported and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.As the device was not returned for analysis, the investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

Subsequent to filing the initial report, 48 unused/sterile devices were received.A random sample of 13 returned unused sterile devices were tested with no anomalies noted.

• Brand Name: 20/30 PRIORITY PACK INDEFLATOR
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10935314
• MDR Text Key: 219186760
• Report Number: 2024168-2020-10093
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013591
• UDI-Public: 08717648013591
• Combination Product (y/n): N
• PMA/PMN Number: K961471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 1000184
• Device Catalogue Number: 1000184
• Device Lot Number: 60198527
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 12/07/2020; 10/07/2021
• Supplement Dates FDA Received: 12/30/2020; 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1