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

Model Number	367878
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® lithium heparinn (lh) blood collection tube there were molding defect sharp protrusions.This event was reported to have affected 6000 device.The following information was provided by the initial reporter.The customer stated: "when the outer package was opened, it was found that the edge of the cap of the green tube had missing or rough edges, which affected the clinical customers' use and the rough edges pierced the customers' fingers.".
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 when using the bd vacutainer® lithium heparinn (lh) blood collection tube there were molding defect sharp protrusions.This event was reported to have affected 6000 device.The following information was provided by the initial reporter.The customer stated: "when the outer package was opened, it was found that the edge of the cap of the green tube had missing or rough edges, which affected the clinical customers' use and the rough edges pierced the customers' fingers.".
Additional Manufacturer Narrative
H.3.Investigation summary: bd had not received samples, but one (1) photo was returned by the customer in support of this complaint.Visual examination of photo was performed and revealed damage to the hemogard closure.Evaluation of the photo confirmed the presence of damage as a notch can be seen at the top edge of the hemogard closure.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 has been confirmed for the indicated failure mode damage to hemogard closure.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER® 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: 15826741
• Report Number: 1917413-2022-00726
• Device Sequence Number: 17681384
• Product Code: JKA
• UDI-Device Identifier: 50382903678780
• UDI-Public: 50382903678780
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/22/2022

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: 06/30/2023
• Device Model Number: 367878
• Device Catalogue Number: 367878
• Device Lot Number: 2018862
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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