MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367283
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.The manufacturing location for this product is nipro.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that during the use of 12 bd vacutainer® safety-lok¿ blood collection set, the luer adapter separated from the vacutainer and was very difficult to reconnect to complete the procedure.No patient or user impact reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 14-mar-2025.Investigation summary: bd received 161 sets of samples (9 sets, 50 sets, 51 sets and 51 sets from each 4 inner boxes) and one (1) photo for investigation.The photo was reviewed and the indicated failure mode for separation/inability to attach was observed.Additionally, the customer samples along with 50 retention samples from bd inventory, were evaluated by visual examination and no abnormalities such as disconnection or loosening of the connection between the luer connector and the luer adapter, or damage and molding defects of the tapers of either component were found.Also, a functional testing was conducted on the returned samples of 32 sets (8 sets from each 4 inner box) and our retained samples of 8 sets of the lot concerned, and no luer adapters disconnected from the luer connectors, and no leakage as well.After the test, additional returned samples of 24 sets (8 sets from each 3 inner box) and additional retained samples of 8 sets which were not used for functional testing, were used to measure the taper dimension by connecting the luer adapters and luer connectors to the taper gauges and all samples met specifications.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 separation/inability to attach based on the photo analysis.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 the use of 12 bd vacutainer® safety-lok¿ blood collection set, the luer adapter separated from the vacutainer and was very difficult to reconnect to complete the procedure.No patient or user impact reported.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21752247
• Report Number: 2243072-2025-00421
• Device Sequence Number: 18597263
• Product Code: JKA
• UDI-Device Identifier: 30382903672838
• UDI-Public: (01)30382903672838(11)240928(17)270630(10)24G1981
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 367283
• Device Lot Number: 24G1981
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2024
• 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