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

Model Number	367963
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tube there was a broken lid/cap/hemogard shield.The following information was provided by the initial reporter.The customer stated: "the rubber stopper was assembled incorrectly.".
Additional Manufacturer Narrative
H.6.Investigation: bd received 2 photos from the customer in support of this complaint.A visual examination of photos was performed and revealed improper assembly.The improper assembly of the shield and stopper can happen at the metro where the stopper is placed/pushed into the shield.If a stopper goes into the rail crooked or cocked it can potentially go into a shield and be placed on a tube.Bd was able to confirm the customer¿s indicated failure mode with the photos provided.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 h3 other text : see h.10.
Event or Problem Description
It was reported when using the bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tube there was a broken lid/cap/hemogard shield.The following information was provided by the initial reporter.The customer stated: "the rubber stopper was assembled incorrectly.".

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE
• 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: 13455637
• Report Number: 1917413-2022-00050
• Device Sequence Number: 4853827
• Product Code: JKA
• UDI-Device Identifier: 50382903679633
• UDI-Public: 50382903679633
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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: 08/31/2022
• Device Model Number: 367963
• Device Catalogue Number: 367963
• Device Lot Number: 1228175
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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