MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER; CATHETER,CANNULA&TUBING,VASC.BYPASS

Model Number 70106.3533

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013, (b)(6) hospital opened a box of avalon elite bi-caval dual lumen catheter 16fr with lot am007537 and identified avalon elite bi-caval dual lumen catheter 19fr (lot 100216827006) inside the box.(b)(4).

Manufacturer Narrative

(b)(4).Avalon was contacted regarding this event.Avalon determined that the two lots were manufactured two years apart and at two different manufacturing site.Lot 100216827006 was manufactured on 02/2010 and expired on 01/2013.Lot am007537 was manufactured on 02/12 and expired on 01/2015.Therefore, it was physically impossible for avalon to have made a labeling error.Additionally, the customer did receive both lots.Lot 100216827006 was shipped on 07/13/2010 and lot am007537 was shipped on 05/03/2012.Note: the product was not shipped by maquet entity.(b)(4).

• Brand Name: AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER
• Type of Device: CATHETER,CANNULA&TUBING,VASC.BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4278488
• MDR Text Key: 5294540
• Report Number: 8010762-2014-00499
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2013

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: 01/31/2013
• Device Model Number: 70106.3533
• Device Catalogue Number: 10016
• Device Lot Number: 100216827006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/29/2013
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2013
• Initial Date Manufacturer Received: 05/29/2013
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1