MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368589
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2018
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.
Event or Problem Description
It was reported that bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes contained foreign matter that appears to be a hair.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode foreign matter with the incident lot was observed.Evaluation of the customer samples was performed and foreign matter was observed.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.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Root cause description: based on the investigation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.
Event or Problem Description
It was reported that bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes contained foreign matter that appears to be a hair.No serious injury or medical intervention was reported.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 18 MG 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: 7748156
• Report Number: 1917413-2018-03176
• Device Sequence Number: 1939213
• Product Code: JKA
• UDI-Device Identifier: 50382903685894
• UDI-Public: 50382903685894
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: BK980011
• 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): 08/27/2018

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 Expiration Date: 12/31/2019
• Device Catalogue Number: 368589
• Device Lot Number: 7340973
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 08/27/2018
• 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