MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367283
Medical Device Problem Codes	Product Quality Problem (1506); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when using the bd vacutainer® safety-lok¿ blood collection set, there is difficulty activating the safety mechanism of an unspecified number of units, causing an unspecified number of used needle stick injuries to users.Reported verbatim: "recently, a good number of needle stick injuries have happened when an employee attempts to initiate the safety mechanism on the wingset needle after a blood draw is complete.A lot of the times, the employee says that the mechanism gets stuck and their fingers slip, causing the needle stick injury.".
Additional Manufacturer Narrative
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.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.
Additional Manufacturer Narrative
After continued follow up with the customer, additional information was provided by the customer indicating the specific number of used needle stick injuries experienced.The following fields have been updated.With additional information: b5.Describe event.
Event or Problem Description
Report 1 of 4, it was reported that when using one (1) bd vacutainer® safety-lok¿ blood collection set, there is difficulty activating the safety mechanism, causing a used needle stick injury to the user.Reported verbatim: "recently, a good number of needle stick injuries have happened when an employee attempts to initiate the safety mechanism on the wingset needle after a blood draw is complete.A lot of the times, the employee says that the mechanism gets stuck and their fingers slip, causing the needle stick injury.Update: there were a total of 4 employees who sustained needle stick injury after use of butterfly.One was in outpatient hiv clinic, one in 4e, one in 3e, and one in 6w icu.3 closed cases due to negative source lab results and the fourth remain open until 4 months post-exposure due to +hiv source.No employees required hospitalization.".
Event or Problem Description
Report 1 of 4.It was reported that when using one (1) bd vacutainer® safety-lok¿ blood collection set, there is difficulty activating the safety mechanism, causing a used needle stick injury to the user.Reported verbatim: "recently, a good number of needle stick injuries have happened when an employee attempts to initiate the safety mechanism on the wingset needle after a blood draw is complete.A lot of the times, the employee says that the mechanism gets stuck and their fingers slip, causing the needle stick injury.Update: there were a total of 4 employees who sustained needle stick injury after use of butterfly.One was in outpatient hiv clinic, one in 4e, one in 3e, and one in 6w icu.3 closed cases due to negative source lab results and the fourth remain open until 4 months post-exposure due to +hiv source.No employees required hospitalization.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: h.1: a0201 - product quality problem (1506).Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.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
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23716172
• Report Number: 2243072-2025-01440
• Device Sequence Number: 21401415
• Product Code: JKA
• UDI-Device Identifier: 00382903672837
• UDI-Public: (01)00382903672837
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 367283
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 02/09/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/05/2026; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown