FDA Adverse Event Injury Summary report: N

SURE COMFORT INSULIN SYRINGES 3/10 CC FOR 30 UNITS OR LESS

MDR report key: 1902947 · Received November 12, 2010

Report

Report Number
MW5018232
Event Type
Injury
Date Received
November 12, 2010
Report Date
November 12, 2010
Manufacturer
ALLISON MEDICAL INC.
Product Code
FMI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I AM AN INSULIN DEPENDENT DIABETIC. I HAVE ENCOUNTERED A MAJOR PROBLEM WITH MY LATEST SHIPMENT OF INSULIN SYRINGES. I APPROACHED MY PHARMACIST, AND HE SAID TO FILE A REPORT. I HAVE NEVER SEEN ANYTHING LIKE THIS IN MY DIABETIC HISTORY. I AM ALSO A REGISTERED NURSE, AND HAVE NEVER SEEN ANYTHING LIKE THIS IN MY 40 YR CAREER. THIS BOX OF SYRINGES HAS HAD CRACKED CAPS. I USE 1/2 ML -30 UNIT- SYRINGES. ONE BOX CONTAINS 10 PACKAGES OF 10 SYRINGES EACH. EACH PACKAGE HAS HAD AT LEAST 8 SYRINGES WITH CRACKED CAPS. THIS IS A STERILITY PROBLEM. NOT ONLY A STERILITY PROBLEM, BUT A NEEDLE STICK PROBLEM !! TWO BIG CONCERNS. I CAN SEE ONE SYRINGE CAP BEING CRACKED, BUT NOT A HUNDRED OF THEM. SOMETHING IS WRONG. OUR PHARMACIST LOOKED AT THE CAPS, AND MY DAUGHTER A PARAMEDIC LOOKED AT THEM. WE ALL ARE IN AGREEMENT, THIS APPEARS TO BE A MFG PROBLEM. -NOT A SHIPPING, OR A WEATHER PROBLEM.- HERE ARE THE NUMBERS AND COMPANY INFO FOR YOU. SURE COMFORT INSULIN SYRINGES 3/10 CC FOR 30 UNITS OR LESS; 5/16" LENGTH SLIMLINE NEEDLE, 31 GAUGE NEEDLE; 100 SINGLE USE SYRINGES. MFG FOR ALLISON MEDICAL INC. (B)(4). (B)(4), ITEM # 22-6503, LOT # 00415. DOSE OR AMOUNT: UP TO 30 UNITS OF INSULIN. FREQUENCY: 4 TIMES A DAY. ROUTE: IM. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: INSULIN DEPENDENT DIABETIC. USED FOR INSULIN. I USE THESE SYRINGES AT LEAST 4 TIMES A DAY. MORE IF I NEED COVERAGE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SURE COMFORT INSULIN SYRINGES 3/10 CC FOR 30 UNITS OR LESS INSULIN SYRINGES FMI ALLISON MEDICAL INC. 00415

Patients

Seq Age Sex Outcome Treatment
1 Other| S