Skip to content

BD Hypoint™ 300208Recalls & reported problems

Becton Dickinson Medical (S) Pte Ltd · BD Hypoint™ Needle 26G x 1/2" (0.45mm x 13mm) · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903002085), received between Nov 15, 2017 and Aug 25, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Contamination of Device Ingredient or Reagent1
  • Delivered as Unsterile Product1
  • Unsealed Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1
  • Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 25, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

    IT WAS REPORTED WHILE USING BD HYPOINT NEEDLE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE TO INFORM YOU THAT WE HAVE BEEN INFORMED BY OUR CUSTOMER THAT THE GLUE ON THE RECEIVED NEEDLE IS TOO FAR TOWARDS THE TIP OF THE NEEDLE. PLEASE LET US KNOW IF IT IS SAFE TO USE SUCH NEEDLES OR NOT, BECAUSE THE GLUE IS ALSO IN CONTACT WITH THE PUNCTURE SITE. WE URGENTLY NEED AN OFFICIAL STATEMENT FROM YOU CONFIRMING THE SAFETY (IF THIS IS THE CASE). IS THERE ALSO A SPECIFICATION OF THE NEEDLE THAT REFLECTS THE AMOUNT OF ADHESIVE? THERE IS THE AUTHORITY (REGIERUNG OBERBAYERN) INVOLVED. THEREFORE WE NEED A FEEDBACK / STATEMENT FROM YOU UNTIL NEXT FRIDAY ((B)(6) 2023).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17627826 ↗
  • InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE HYPOINT NDL26GA1/2IN WAS INVOLVED IN A CASE OF SERIOUS INJURY -INFECTION WHICH OCCURRED DURING USE. THE PATIENT REPORTED "SKIN AND TISSUE" STICKING TO THE NEEDLE AFTER PULLING IT OUT, LEAVING "BLOODY SPOTS ON THE ABDOMEN" AND A SUBSEQUENT INFECTION. IT HAS NOT BEEN SPECIFIED WHETHER ANY MEDICAL TREATMENT WAS ADMINISTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER CLAIMS THAT THE NEEDLE IS BLUNT AND DIFFICULT TO PASS THROUGH THE ABDOMINAL WALL. WHEN THE NEEDLE WAS PULLED OUT, SKIN AND TISSUE STUCK TO THE NEEDLE. THERE WERE BLOODY SPOTS ON THE ABDOMEN THAT BECAME INFECTED.

    Patient problems: Unspecified Infection

    MAUDE report 9812986 ↗
  • MalfunctionNov 15, 2017Delivered as Unsterile Product; Unsealed Device Packaging

    IT WAS REPORTED THAT THE CONSUMER RECEIVED A BD HYPOINT¿ NEEDLE THAT WAS NOT SEALED CAUSING THEM TO QUESTION THE STERILITY OF THE NEEDLE. THE PRODUCT WAS NOT USED AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7035621 ↗

Other Needle, hypodermic, single lumen devices

All Needle, hypodermic, single lumen devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.