MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368653
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
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 that during use with bd vacutainer® safety-lok¿ blood collection set with pre-attached holder the cannula was clogged.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: no draw in tube.It is possible for slbcs to clog.
Event or Problem Description
It was reported that during use with bd vacutainer® safety-lok¿ blood collection set with pre-attached holder the cannula was clogged.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: no draw in tube.It is possible for slbcs to clog.
Additional Manufacturer Narrative
The following fields have been updated.D10: device available for evaluation? yes.D10: returned to manufacturer on 22-aug-2023.H.6.Investigation summary: material #: 368653, lot/batch #: 2165525.Bd received 2 used samples for investigation.The samples were evaluated by visual examination and the tubing of the samples were found to be damaged / stuck together.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 damaged tubing.Bd determined that the root cause of the indicated failure mode was attributed to a leak in the tubing welding agent supply line.The welding agent contacted the tubing and caused it to stick to itself.The leaking supply line has since been replaced.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.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17621201
• Report Number: 1024879-2023-00598
• Device Sequence Number: 17680846
• Product Code: JKA
• UDI-Device Identifier: 50382903686532
• UDI-Public: 50382903686532
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K980414
• 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): 10/24/2023

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: 368653
• Device Lot Number: 2165525
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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