MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367842
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that there was low blood draw with a bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes.This occurred on 20 separate occasions, however, the patient information is unknown.The following information was provided by the initial reporter: it is reported 20 vacutainers displayed no vacuum.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through capa#260774.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.
Event or Problem Description
It was reported that there was low blood draw with a bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes.This occurred on 20 separate occasions, however, the patient information is unknown.The following information was provided by the initial reporter: it is reported 20 vacutainers displayed no vacuum.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9161921
• Report Number: 1917413-2019-02167
• Device Sequence Number: 2157053
• Product Code: JKA
• UDI-Device Identifier: 50382903678421
• UDI-Public: 50382903678421
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K981013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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 Expiration Date: 02/29/2020
• Device Catalogue Number: 367842
• Device Lot Number: 8303652
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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