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

Model Number	368589
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/11/2020
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 foreign matter was discovered with a bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes.The following information was provided by the initial reporter: it was reported that the tube was dirty/stained.
Additional Manufacturer Narrative
The following fields were updated due to additional information: b3 date of event:(b)(6) 2020.H6: result codes: 114.H6: conclusion codes: 4315.H6: investigation summary bd had not received samples, but 1 photos were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for foreign matter- debris with the incident lot was observed.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.
Event or Problem Description
It was reported that foreign matter was discovered with a bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes.The following information was provided by the initial reporter: it was reported that the tube was dirty/stained.
Event or Problem Description
It was reported that foreign matter was discovered with a bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes.The following information was provided by the initial reporter: it was reported that the tube was dirty/stained.
Additional Manufacturer Narrative
H6: investigation summary 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) 18 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: 10718616
• Report Number: 1917413-2020-00982
• Device Sequence Number: 11676691
• Product Code: JKA
• UDI-Device Identifier: 50382903685894
• UDI-Public: 50382903685894
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: BK980011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020

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: 02/28/2021
• Device Model Number: 368589
• Device Catalogue Number: 368589
• Device Lot Number: 9036815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020; 11/11/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 11/02/2020; 11/11/2020
• 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