MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® SERUM BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368660
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2018
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.
Event or Problem Description
It was reported that the bd vacutainer® serum blood collection tubes had collapsed tubes caused no serious injury medical intervention.
Additional Manufacturer Narrative
Correction: short description was reported incorrectly on the initial mdr.The correct description is: it was reported that the bd vacutainer® serum blood collection tubes looked melted.No serious injury or medical intervention was reported.Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for collapsed tubes with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Based on evaluation of the customer samples, the customer¿s indicated failure mode for collapsed tubes with the incident lot was observed.This complaint investigation was handled under the premise of a previously investigated issue specific for collapsed tubes, where it was determined that the results and conclusions established in the previous investigations pointed to the same indicated failure mode and root causes observed in the current complaint investigation.Additionally, the conclusion drawn from the current complaint investigation did not yield new information regarding the indicated failure mode.Complaint data for this failure mode is monitored and trended on a routine basis.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd vacutainer® serum blood collection tubes looked melted.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
Event or Problem Description
It was reported that the bd vacutainer® serum blood collection tubes looked melted.No serious injury or medical intervention was reported.

• Brand Name: BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7589005
• Report Number: 1917413-2018-02020
• Device Sequence Number: 11311107
• Product Code: JKA
• UDI-Device Identifier: 50382903686600
• UDI-Public: 50382903686600
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 368660
• Device Lot Number: 7180600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 02/02/2018; 02/02/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 07/17/2018; 10/02/2018
• 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