MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367855
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device manufacture date: unknown.(b)(4).Investigation summary: the customer did not provide bd pas with lot number information, when requested.After 3-follow-up attempts to obtain additional information, bd pas has closed this customer complaint.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.
Event or Problem Description
It was reported that after use with 3 bd vacutainer® edta (k2e) 5.4mg blood collection tubes it was discovered that the tubes were expired.The following information was provided by the initial reporter: lab manager called in requesting information in regards to using expired vacutainers and the possible outcomes.No date of event, 3 occurrences at this time.There is no erroneous results to report at this time but patients will be called in to be redrawn.No lot information at this time but expiration date was 07/31/2020.

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 5.4MG 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: 10544042
• Report Number: 1917413-2020-00827
• Device Sequence Number: 3074418
• Product Code: GIM
• UDI-Device Identifier: 50382903678551
• UDI-Public: 50382903678551
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K971449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 07/31/2020
• Device Model Number: 367855
• Device Catalogue Number: 367855
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/16/2020
• 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