MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367874
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with 2 lots of bd vacutainer® sodium heparin (nh) 158 usp units blood collection tubes an unspecified amount of them had vacuum issues.There was no report of patient impact.The following information was provided by the initial reporter: customer states product exhibits vacuum issue.
Additional Manufacturer Narrative
"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 2259076.D.4.Medical device expiration date: 30-sep-2024.H.4.Device manufacture date: 16-sep-2022.D.4.Medical device lot #: 2347079.D.4.Medical device expiration date: 31-dec-2024.H.4.Device manufacture date: 13-dec-2022.E.1.Initial reporter state: address information was not able to be obtained, therefore, nj was used as a place holder.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: bd had not received samples or photos for investigation.Therefore, one hundred (100) retention samples each (lot numbers 2347079 and 2259076) from bd inventory were evaluated by visual examination with the hemogram closure assembly correctly assembled and placed on the tubes.Additionally, ten (10) retention samples each (lot numbers 2347079 and 2259076) from bd inventory were evaluated by functional draw testing and no issues were observed relating to underfill as all samples met specifications.Based on a review of the device history record for the incident lots, 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 underfill with the investigation completed.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that during use with 2 lots of bd vacutainer® sodium heparinn (nh) 158 usp units blood collection tubes an unspecified amount of them had vacuum issues.There was no report of patient impact.The following information was provided by the initial reporter: customer states product exhibits vacuum issue.

• Brand Name: BD VACUTAINER® SODIUM HEPARINN (NH) 158 USP UNITS 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: 17725831
• Report Number: 1917413-2023-00895
• Device Sequence Number: 20637942
• Product Code: JKA
• UDI-Device Identifier: 50382903678742
• UDI-Public: 50382903678742
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K944566
• 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): 09/18/2023

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: 367874
• Device Lot Number: SEE H.10
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 09/20/2023
• 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