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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
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 the bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes experienced discolored / abnormal additive form.The following information was provided by the initial reporter.The customer stated: it was reported that the plasma looks like jelly."i am reaching out as related to the 10 ml k2edta tube, lot #0167257, exp 06-30-22.We are seeing issues now with approximately 6-7 specimens in which the plasma is described as being like jelly.Have you heard of any issues of this nature from anywhere else.We are wondering if it is this specific lot number alone, as this is the only lot number we currently have on hand for both of our hospital campuses.".
Event or Problem Description
It was reported the bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes experienced discolored / abnormal additive form.The following information was provided by the initial reporter.The customer stated: it was reported that the plasma looks like jelly."i am reaching out as related to the 10 ml k2edta tube, lot #0167257, exp 06-30-22.We are seeing issues now with approximately 6-7 specimens in which the plasma is described as being like jelly.Have you heard of any issues of this nature from anywhere else.We are wondering if it is this specific lot number alone, as this is the only lot number we currently have on hand for both of our hospital campuses.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-03-29.H6: investigation summary : bd received 10 contaminated returned samples.Testing cannot be performed on used samples.Therefore, retention samples from bd inventory were evaluated for any additive issues.All testing was within specification.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 issues during manufacturing of the product.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.

• 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: 11628541
• Report Number: 1917413-2021-00270
• Device Sequence Number: 19749807
• Product Code: JKA
• UDI-Device Identifier: 50382903685894
• UDI-Public: 50382903685894
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: BK980011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/13/2021

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: 06/30/2022
• Device Model Number: 368589
• Device Catalogue Number: 368589
• Device Lot Number: 0167257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1