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

Model Number	366480
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
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 prior to use with 300 bd vacutainer® sodium heparin (nh) blood collection tubes the additive was dried out.The following information was provided by the initial reporter: dried out additive.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and the indicated failure mode for additive abnormality with the incident lot was not observed.The photo shows tubes in a shelf pack upside down.After the additive is placed into the tube it is then put through a freeze-dried process generating the vacuum.The small white free-floating discs¿ seen in the photo is the additive.This is the normal appearance of the additive pellet for product 366480.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 the indicated failure mode of additive abnormality.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported that prior to use with 300 bd vacutainer® sodium heparin (nh) blood collection tubes the additive was dried out.The following information was provided by the initial reporter: dried out additive.

• Brand Name: BD VACUTAINER® SODIUM HEPARIN¿ (NH) BLOOD COLLECTION 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 ; 8448235433
• MDR Report Key: 16892305
• Report Number: 1917413-2023-00399
• Device Sequence Number: 17847268
• Product Code: JKA
• UDI-Device Identifier: 50382903664806
• UDI-Public: (01)50382903664806
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 07/05/2023

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: 02/28/2025
• Device Model Number: 366480
• Device Catalogue Number: 366480
• Device Lot Number: 3048749
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2023
• 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