MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 15.8 MG; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	362799
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0072402, medical device expiration date: 2021-03-31, device manufacture date: 2020-03-12.Medical device lot #: 0100181, medical device expiration date: 2021-04-30, device manufacture date: 2020-04-09.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 the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg experienced clotting/micro clots/fibrin clots.This event occurred 2 times.The following information was provided by the initial reporter: translated to english.The customer stated: there was "observation of fibrin and clot particles after melting the frozen tubes.These tubes collected depend on instruction for use these tubes, we checked the process of workflow and check the qc of the centrifuge they use and everything was accepted.".
Event or Problem Description
It was reported the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg experienced clotting/micro clots/fibrin clots.This event occurred 2 times.The following information was provided by the initial reporter: translated to english.The customer stated: there was "observation of fibrin and clot particles after melting the frozen tubes.These tubes collected depend on instruction for use these tubes, we checked the process of workflow and check the qc of the centrifuge they use and everything was accepted.".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples, but 1 video was provided for investigation.The video was reviewed.The video shows a substance in the serum which is common if sample was frozen.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to fibrin were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure (fibrin/fibrin clots.) because the defect was not evident in the testing of the retention lot samples.Evaluation of both retain and control samples tested were acceptable.All samples demonstrated clinically acceptable performance for all visual observations evaluated.Retention samples were also tested for anticoagulant content and all tubes met specifications.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 unable to confirm this complaint for fibrin.Bd was not able to identify a root cause for the indicated failure mode.See h.10.

• Brand Name: BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 15.8 MG
• 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: 11186835
• Report Number: 1917413-2021-00030
• Device Sequence Number: 16782112
• Product Code: JKA
• UDI-Device Identifier: 50382903627993
• UDI-Public: 50382903627993
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K972075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,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 Model Number: 362799
• Device Catalogue Number: 362799
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1