HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE

Report

• Report Number: MW5028573
• Date Received: January 7, 2013
• Date of Event: January 6, 2013
• Report Date: January 7, 2013
• Manufacturer: SMITHS MEDICAL ASD, INC
• Product Code: FMF
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Location: FL, US
• Reporter Occupation: PHARMACIST

Narratives

Description of Event or Problem · 1

PHARMACY DEPT IV ROOM OPENED ANOTHER BRAND NEW BOX OF U-100 INSULIN SYRINGES, NEW LOT NUMBERS AND FOUND MOST ALL NEEDLE TIPS COATED IN RUST. ALL ARE SEALED AS WELL AS THE TWO BOXES THAT WE OPENED WERE SEALED UNTIL (B)(6) 2013. THE PHARMACY DEPT AT THIS FACILITY IS THE ONLY DEPT AT THIS FACILITY THAT USES THIS BRAND OF U-100 INSULIN SYRINGE. THEY WERE JUST RECEIVED FROM THE SUPPLIER THIS PAST WEEK AND HAVE BEEN STORED AT CONTROLLED ROOM TEMP. ALSO SEE (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
8431	HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE	1 ML 29G X 1/2 IN U-100 INSULIN SYRINGE	FMF	SMITHS MEDICAL ASD, INC	*	2353091

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Patient Involvement

Product problems · 2

• Corroded
• Out-Of-Box Failure

Type of report · 1

• Initial submission