MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	366667
Medical Device Problem Codes	Positioning Problem (3009); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
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 bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes customer states cap pops off tube before filling.The following information was provided by the initial reporter.The customer stated: "customer states cap pops off tube before filling.¿.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The following fields have been updated: b.5 it was reported that bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes customer states cap pops off tube before filling and also the tube will slide off of the luer.The following information was provided by the initial reporter.The customer stated: "customer states cap pops off tube before filling.¿ customer states when insert tube into needle luer it will begin to fill, then the tube will slide off of the luer.
Event or Problem Description
It was reported that bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes customer states cap pops off tube before filling and also the tube will slide off of the luer.The following information was provided by the initial reporter.The customer stated: "customer states cap pops off tube before filling.¿ customer states when insert tube into needle luer it will begin to fill, then the tube will slide off of the luer.
Additional Manufacturer Narrative
Bd had not received samples or photos for investigation.Therefore, one hundred (100) retention samples from bd inventory were evaluated by visual examination and no issues were observed, all stoppers and hemogards were assembled correctly.All samples met specifications.Additionally ten (10) retention samples were evaluated by functional testing and no issues were observed relating to tube push off as all samples met specifications.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.This complaint is unable to be confirmed for decapping issues or tube push off.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
Event or Problem Description
It was reported that bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes customer states cap pops off tube before filling and also the tube will slide off of the luer.The following information was provided by the initial reporter.The customer stated: "customer states cap pops off tube before filling.¿ customer states when insert tube into needle luer it will begin to fill, then the tube will slide off of the luer.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15033042
• Report Number: 1917413-2022-00407
• Device Sequence Number: 6929765
• Product Code: JKA
• UDI-Device Identifier: 50382903666671
• UDI-Public: 50382903666671
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• 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,Followup
• Report Date (Section B): 09/29/2022

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 Expiration Date: 04/30/2023
• Device Model Number: 366667
• Device Catalogue Number: 366667
• Device Lot Number: 1350304
• 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: 07/01/2022
• Supplement Date Received by Manufacturer: 07/01/2022; 09/29/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 09/12/2022; 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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