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

Model Number	367977
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter email: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ blood collection tubes, the device experienced molding defect (short shot).This event occurred once.The following information was provided by the initial reporter.The customer stated: customer states tube is curved at top causing pipetting errors on instrument.
Additional Manufacturer Narrative
H.6.Investigation summary: "bd had not received samples, but one (1) photo was provided for investigation.After review and analysis of the customers photo, bd is able to confirm the product defect.Bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.Bd was not able to identify a root cause for the indicated failure mode.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.".
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ blood collection tubes, the device experienced molding defect (short shot).This event occurred once.The following information was provided by the initial reporter.The customer stated: "customer states tube is curved at top causing pipetting errors on instrument.".

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15951363
• Report Number: 1024879-2022-00706
• Device Sequence Number: 7303339
• Product Code: JKA
• UDI-Device Identifier: 50382903679770
• UDI-Public: 50382903679770
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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 Model Number: 367977
• Device Catalogue Number: 367977
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown