MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® EDTA 2K; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367846

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

Bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for (b)(6) with the incident lot was observed.

Event Description

It was reported that bd vacutainer® edta 2k "edta-367846-fm (embedded).".

Manufacturer Narrative

Medical device type: corrected to jka.Pma / 510(k)#: corrected to k981013.

• Brand Name: BD VACUTAINER® EDTA 2K
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7475806
• MDR Text Key: 107697640
• Report Number: 1917413-2018-01211
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K981013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 367846
• Device Lot Number: 7016673
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other