FDA Adverse Event Malfunction Summary report: N

18G HYPODERMIC NEEDLE

MDR report key: 21504104 · Received March 3, 2025

Report

Report Number
MW5167118
Event Type
Malfunction
Date Received
March 3, 2025
Report Date
February 27, 2025
Manufacturer
MEDLINE INDUSTRIES, INC.
Product Code
OES
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

WE ARE SEEING A TREND WITH CORING / DISLODGEMENT OF VIAL RUBBER STOPPERS WHEN ATTEMPTING TO ADMINISTER MEDICATIONS. INITIALLY, THE CONCERN WAS FOR THE BLUNT TIP NEEDLES / CANNULAS TYPICALLY USED BY FRONTLINE STAFF TO DRAW UP MEDICATIONS TO BE ADMINISTERED IV. AS WE BEGAN TRACKING OUR REPORTING, WE HAVE SEEN INCONSISTENCIES IN THE DRUG PRODUCTS, MFRS OF NEEDLES AND MEDICATIONS, AS WELL AS VARIANCES AMONG THE ACTUAL PRODUCT DEFECT. THERE HAS BEEN CORING, PUSHING THE ENTIRE STOPPER INTO THE VIAL AND FRAGMENTS / PIECES OF THE STOPPER BREAKING AND FALLING IN. I WILL ATTACH SOME EXAMPLE PICTURES. MEDICATIONS: PROCRIT 10,000U INJ/VIAL, JANSSEN BIOTECH FENTANYL CITRATE PF 50MCG/ML INJ/VIAL, HOSPIRA / PFIZER (MULTIPLE) METHYLPREDNISOLONE, PFIZER CYANOCOBALAMIN, VITAMIN B12 INJ/VIAL, AMERICAN REGENT HEPARIN 10000 UNIT/10ML, INJ, FRESENIUS KABI (MULTIPLE) APREPITANT 130MG/18ML, INJ, HERON THERAPEUTICS, INC. LIDOCAINE WITH EPI (1%), 30ML INJ, UNK CANNULA / NEEDLES: BD NEEDLE 1.5IN 18GA FILL STERILE BLUNT, BD LATEX FREE REF 305180, BD CANNULA INJECTION 17GA BLUNT STERILE LATEX FREE, BD PLASTIC REF 303345, COVIDIEN, NEDDLELESS MED PREP CANNULAS, REF 8881540111 COVIDIEN, NEEDLELES MED PREP CANNULAS, REF 8881850310 MEDLINE, 18G HYPODERMIC NEEDLE REF DYNJ60655D, LOT# 24GMA342. (B)(4). REFERENCE REPORT #MW5167114, #MW5167115, #MW5167116, #MW5167117.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2630561 18G HYPODERMIC NEEDLE CARDIAC CATHETERIZATION KIT OES MEDLINE INDUSTRIES, INC. 24GMA342

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown APREPITANT - HERON THERAPEUTICS 130 MG/18 ML | CYANOCOBALAMIN - AMERICAN REGENT INC. | FENTANYL CITRATE PRESERVATIVE FREE - HOSPIRA, INC. 50 MCG/ML | HEPARIN - FRESENIUS KABI USA INC. 10,000 UNITS / 10 ML | IRON SUCROSE - AMERICAN REGENT INC. | LIDOCAINE HCL AND EPINEPHRINE 1% 30 ML | LORAZEPAM 2 MG/ML | METHERGINE | METHYLPREDNISOLINE - PFIZER INC. | PROCRIT - JANSSEN BIOTECH INC. 10,000 UNITS| SOLU-CORTEF - PFIZER INC. 100 MG PER VIAL