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	368056
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
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 the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg experienced no label or missing label information.This event occurred 2 times.The following information was provided by the initial reporter: translated to english.The customer stated "that two pcs were found without label.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 11/23/2020.H.6.Investigation: bd received 2 samples and 2 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for missing label and defective stopper with the incident lot was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for missing label and defective stopper with the incident lot was observed.Bd determined that the root cause of the indicated failure mode was attributed to assembly related.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.H3 other text : see h.10.
Event or Problem Description
It was reported the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg experienced no label or missing label information.This event occurred 2 times.The following information was provided by the initial reporter: translated to english.The customer stated "that two pcs were found without label.".

• 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: 10877744
• Report Number: 1917413-2020-01174
• Device Sequence Number: 3738233
• Product Code: JKA
• UDI-Device Identifier: 50382903680561
• UDI-Public: 50382903680561
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 01/25/2021

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: 03/31/2021
• Device Model Number: 368056
• Device Catalogue Number: 362799
• Device Lot Number: 0072402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1