MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® K3 EDTA (K3E) 12MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366450
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Initial reporter phone#: (b)(6).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 or Problem Description
It was reported that the bd vacutainer® k3 edta (k3e) 12mg blood collection tubes had clotting issues.
Additional Manufacturer Narrative
Pma / 510(k)# is corrected to preamendment.

• Brand Name: BD VACUTAINER® K3 EDTA (K3E) 12MG BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7477716
• Report Number: 1917413-2018-02506
• Device Sequence Number: 1476669
• Product Code: PJE
• UDI-Device Identifier: 50382903664509
• UDI-Public: 50382903664509
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 366450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2016
• Supplement Date Received by Manufacturer: 01/29/2016
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other