MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367977
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there have been bd vacutainer® sst¿ blood collection tube issues 30% of samples hemolyzed.The following information was provided by the initial reporter: customer reporting 30% of samples hemolyzed for product 367977.
Additional Manufacturer Narrative
D4: lot:unknown.D4: expiration date:unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.In this mdr, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.As lot information is unknown.H4: device manufacture date: unknown.
Additional Manufacturer Narrative
H6: investigation summary: no customer samples/photos were received for evaluation.Complaints for sample quality are under statistical control for the month of july 2023.At this time, further testing is not indicated.A review of the dhr could not be performed as the batch number is unknown.This complaint is unable to be confirmed.Bd was unable to determine a root cause.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for monitoring of current trends.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported that there have been bd vacutainer® sst¿ blood collection tube issues 30% of samples hemolyzed.The following information was provided by the initial reporter: customer reporting 30% of samples hemolyzed for product 367977.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17427915
• Report Number: 2243072-2023-01334
• Device Sequence Number: 7571647
• Product Code: JKA
• UDI-Device Identifier: 50382903679770
• UDI-Public: 50382903679770
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• 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): 08/15/2023

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: 367977
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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