MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) 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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 after centrifugation with a bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg sample clotted.This occurred on 10 occasions, however, patient impact was not reported.The following information was provided by the initial reporter, translated from (b)(6) to english: after the centrifugation process, the serum sample is obtained as a clot, which does not allow the separation of the serum.
Event or Problem Description
It was reported that after centrifugation with a bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg sample clotted.This occurred on 10 occassions, however, patient impact was not reported.The following information was provided by the initial reporter, translated from spanish to english: after the centrifugation process, the serum sample is obtained as a clot, which does not allow the separation of the serum.
Additional Manufacturer Narrative
Investigation summary bd had not received samples or photos 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 issues during manufacturing of the product.A complaint history review was conducted and this was the 1st complaint for this defect and lot number.The instructions for use (ifu) for this tube type indicates that the tube must be allowed to clot for 60 minutes before centrifugation to allow proper clot formation.The customer has indicated a 30-minute clot time.Based on the investigation completed, bd was unable to confirm this complaint.A review of specimen handling parameters should be reviewed for this tube type.\.

• 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., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 10751672
• Report Number: 1024879-2020-00765
• Device Sequence Number: 14419238
• Product Code: JKA
• UDI-Device Identifier: 50382903627993
• UDI-Public: 50382903627993
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K972075
• Number of Events Summarized: 1
• Summary Report (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): 11/05/2020

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: 01/31/2021
• Device Model Number: 362799
• Device Catalogue Number: 362799
• Device Lot Number: 9242468
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1