BD Vacutainer® Safety-Lok™ Blood Collection Set 367288Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30382903672883), received between Jan 3, 2024 and Sep 16, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K980414); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792533 ↗
• MalfunctionDec 22, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, (23) UNITS COULD NOT BE CONNECTED TO THE ADAPTOR. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864025 ↗
• MalfunctionNov 3, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE HOLDER CAME OFF OF THE NEEDLE AFTER THE FIRST TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452531 ↗
• MalfunctionOct 21, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE HOLDER SEPARATED FROM THE NEEDLE ON AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347472 ↗
• MalfunctionSep 16, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE HOLDER SEPARATES FROM THE UNIT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064292 ↗
• InjuryMay 30, 2025Product Quality Problem; Physical Resistance/Sticking; Product Quality Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NURSES NOTICED THE NEEDLES ARE FLIMSY AND AN INFERIOR PRODUCT COMPARES TO WHAT THEY HAVE ORDERED IN THE PAST RESULTING IN TWO NEEDLE STICK INJURIES WHEN USING THEM. NO OTHER INFORMATION REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22113607 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Premature Separation; Adverse Event Without Identified Device or Use Problem; Premature Separation

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THERE WAS ONE NEEDLESTICK INJURY AND BLOOD EXPOSURE. THE STAFF MEMBER HAD PLACED THE NEEDLE INTO THE SHARPS CONTAINER AND THE NEEDLE SCRAPED THE PERSON DURING THIS TRANSFER. NO FURTHER INTERVENTION OR MEDICAL TREATMENT WAS REQUIRED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18436525 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K980414. One submission often covers many models, so check the product and lot details in each record.

• Z-0777-2007 · Mar 20, 2007 · Terminated
  BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immedi