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

Catalog Number	369741
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported when using the bd vacutainer® esr blood collection tubes customer found the tubes broken/cracked.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: defect: found that the wall of the blood collection tube was broken quantity: 2.
Event or Problem Description
It was reported when using the bd vacutainer® esr blood collection tubes customer found the tubes broken/cracked.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: defect: found that the wall of the blood collection tube was broken.Quantity: 2.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-08-28.H.6.Investigation summary: material #: 369741.Lot/batch #: 2347113.Bd received 2 samples and 1 photo for investigation.The photo was reviewed and the customer¿s indicated failure mode for broken glass tube was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for broken glass tube with the incident lot was observed.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 broken glass tube.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER® ESR 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17553700
• Report Number: 1917413-2023-00803
• Device Sequence Number: 4880658
• Product Code: JKA
• UDI-Device Identifier: 50382903697415
• UDI-Public: 50382903697415
• 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): 08/16/2023

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: 06/30/2024
• Device Catalogue Number: 369741
• Device Lot Number: 2347113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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