MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	368661
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that before use the bd vacutainer® k2 edta (k2e) 10.8 mg blood collection tubes had foreign matter in tube; biological and nonbiological.The following information was provided by the initial reporter: "customer found there was particulate in the product.".
Event or Problem Description
It was reported that before use the bd vacutainer® k2 edta (k2e) 10.8 mg blood collection tubes had foreign matter in tube; biological and nonbiological.The following information was provided by the initial reporter: "customer found there was particulate in the product.".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer for evaluation.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 10.8 MG 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: 10399462
• Report Number: 1917413-2020-00680
• Device Sequence Number: 14417903
• Product Code: JKA
• UDI-Device Identifier: 50382903686617
• UDI-Public: 50382903686617
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K971449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2021
• Device Model Number: 368661
• Device Catalogue Number: 368661
• Device Lot Number: 9344023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 09/08/2020
• 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