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

Model Number	368056
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® pst¿ gel and lithium heparinn (lh) 65 units blood collection tubes while customer were drawing 2 patients, the tube popped immediately off the hub.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tubes draw 2 patients using the green tiger tops, product 368056 on lot 1288747, and both times the tubes popped immediately off the hub.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with additional information: h.6.Investigation summary: mat: 368056 lot: 1288747 bd received 5 samples and 2 photos from the customer in support of this complaint.The photos were evaluated and show a shelf pack and the case for the product.The 5 samples were visually inspected with no issues being identified.Functional testing was performed on the 5 customer samples and the issue of tube push off was not observed as all results were within specification limits.Additionally, 100 retention samples from the bd inventory were visually inspected with no issues being identified and, 10 retention samples were functionally tested and the issue of tube push off was not observed.Bd was unable to confirm the customer¿s indicated failure mode with the samples and photo returned, the failure mode could was not duplicated in the retention testing.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd vacutainer® pst¿ gel and lithium heparinn (lh) 65 units blood collection tubes while customer were drawing 2 patients, the tube popped immediately off the hub.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tubes draw 2 patients using the green tiger tops, product 368056 on lot 1288747, and both times the tubes popped immediately off the hub.

• 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: 15029095
• Report Number: 1917413-2022-00403
• Device Sequence Number: 17679119
• Product Code: JKA
• UDI-Device Identifier: 50382903680561
• UDI-Public: 50382903680561
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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): 07/20/2022

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: 10/31/2022
• Device Model Number: 368056
• Device Catalogue Number: 368056
• Device Lot Number: 1288747
• 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: 06/23/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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