MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® NAF 3.0MG N2E 6.0MG PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367933

Device Problem Short Fill (1575)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

Bd received photos from the customer facility for investigation, although the photos were not evaluated.This complaint is confirmed to be within the scope of a known issue.Quality has previously reviewed, evaluated and investigated this failure mode.No further action is required at this time.Based on evaluation of the complaint information, this complaint meets the criteria for a previously investigated complaint; reference (b)(4).

Event Description

It was reported that bd vacutainer® naf 3.0mg n2e 6.0mg plus blood collection tubes were underfilled.No serious injury or medical intervention.

• Brand Name: BD VACUTAINER® NAF 3.0MG N2E 6.0MG PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7592857
• MDR Text Key: 111190459
• Report Number: 1917413-2018-02776
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 367933
• Device Lot Number: 6124906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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
• Patient Outcome(s): Other