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

Catalog Number 367846

Device Problem Short Fill (1575)

Patient Problem Death (1802)

Event Date 01/11/2017

Event Type  Death  

Manufacturer Narrative

No lot # provided.Device manufacture date: unknown.Medical device expiration date: unknown.Pma / 510(k) #: there is no 510(k) given for this device.Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.

Event Description

It was reported that bd vacutainer® edta 2k did not draw enough blood.

Manufacturer Narrative

Medical device type updated to (b)(6).The 510(k)# updated 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
• 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: 7485402
• MDR Text Key: 107313749
• Report Number: 1917413-2018-02629
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981013
• 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,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367846
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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