MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	368380
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2020
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.(b)(4).
Event or Problem Description
It was reported that during use with bd vacutainer® trace element serum plus blood collection tubes the gel smearing occurred.This occurred on 3 separate occasions, however, the patient impact was not reported.The following information was provided by the initial reporter: trace element tube gelling.
Event or Problem Description
It was reported that during use with bd vacutainer® trace element serum plus blood collection tubes the gel smearing occurred.This occurred on 3 separate occasions, however, the patient impact was not reported.The following information was provided by the initial reporter: trace element tube gelling.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-01-05.H6: investigation summary: bd received 3 samples and 1 photo for investigation.The photo was reviewed and the indicated failure mode for fibrin with the incident lot was observed.The customer samples were evaluated visually with no issues being identified.Additionally, retention samples of the incident lot selected from bd inventory for further testing.The samples were tested and 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 the customer¿s indicated failure (fibrin) because the defect was not evident in the testing of the complaint lot samples.All samples (complaint lot retains and control samples) demonstrated clinically acceptable performance for all visual observations evaluated.Laboratory analysis of samples indicated that these tubes performed as expected.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.

• Brand Name: BD VACUTAINER TRACE ELEMENT SERUM PLUS 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: 11028942
• Report Number: 1917413-2020-01241
• Device Sequence Number: 10919883
• Product Code: JKA
• UDI-Device Identifier: 50382903683807
• UDI-Public: 50382903683807
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K041071
• 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): 05/11/2021

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: 12/31/2020
• Device Model Number: 368380
• Device Catalogue Number: 368380
• Device Lot Number: 9344018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1