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

Catalog Number	366480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Hold for co 10.24.It was reported that during use for a research project with bd vacutainer® sodium heparin (nh) blood collection tubes the glass tube broke when stored in the freezer.The following information was provided by the initial reporter, translated from dutch to english: i am using your glass vacutainers for my research project.We have had some issues with the glass cracking when the samples are stored in the freezer.We are using the 10ml tubes and filling them with 5ml of blood, and then putting them directly into the freezer.The tubes have cracked in both -20°c and -80°c.It is not an option for us to switch to a plastic product due to the nature of the research.Product information: 366480 plasma tube, 143 usp units of sodium heparin.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown h.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.B3: date of event: has been updated from 28-sep-2023 to 27-sep-2023 b.5.Describe event or problem: it was reported that during use for a research project with bd vacutainer® sodium heparin¿ (nh) blood collection tubes, 40 glass tubes broke when stored in the freezer.The following information was provided by the initial reporter, translated from dutch to english: "i am using your glass vacutainers for my research project.We have had some issues with the glass cracking when the samples are stored in the freezer.We are using the 10ml tubes and filling them with 5ml of blood, and then putting them directly into the freezer.The tubes have cracked in both -20°c and -80°c.It is not an option for us to switch to a plastic product due to the nature of the research.Product information: 366480 plasma tube, 143 usp units of sodium heparin.Product 368480 lot 2175178.This occurred (b)(6) 2023.This has occurred with 40 tubes." h.6.Investigation summary: bd had not received samples, but seven (7) photos were provided for investigation.The photos were reviewed and the indicated failure mode for tube breakage was observed.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issue of tube damage/breakage was not 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 of tube breakage with the provided photos.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported that during use for a research project with bd vacutainer® sodium heparin¿ (nh) blood collection tubes, 40 glass tubes broke when stored in the freezer.The following information was provided by the initial reporter, translated from dutch to english: "i am using your glass vacutainers for my research project.We have had some issues with the glass cracking when the samples are stored in the freezer.We are using the 10ml tubes and filling them with 5ml of blood, and then putting them directly into the freezer.The tubes have cracked in both -20°c and -80°c.It is not an option for us to switch to a plastic product due to the nature of the research.Product information: 366480 plasma tube, 143 usp units of sodium heparin.Product 368480 lot 2175178.This occurred (b)(6) 2023.This has occurred with 40 tubes.".

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17950248
• Report Number: 1917413-2023-01041
• Device Sequence Number: 6565058
• Product Code: JKA
• UDI-Device Identifier: 50382903664806
• UDI-Public: 50382903664806
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: NA
• 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): 11/07/2023

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 Catalogue Number: 366480
• Device Lot Number: UNKNOWN
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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