FDA Adverse Event Malfunction Summary report: N

VACUETTE MULTIPLE USE DRAWING NEEDLE 22G X 1 1/4" BLACK, STERILE

MDR report key: 12225736 · Received July 26, 2021

Report

Report Number: 8020040-2021-00030
Event Type: Malfunction
Date Received: July 26, 2021
Report Date: July 26, 2021
Manufacturer: GREINER BIO-ONE GMBH
Product Code: FMI
PMA / PMN Number: K973620
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

COMPLAINT STATEMENT (B)(4): RECEIVED 21PCS OF 450061/20G23C FOR EVALUATION. RECEIVED CUSTOMER PICTURE. ALSO RECEIVED 81PCS OF 450061/20K19C, WHICH WERE UNRELATED TO THE COMPLAINT. WE HAVE NO REMAINING INVENTORY OF THIS MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS FOR THIS MATERIAL/BATCH. WE FORWARDED THE COMPLAINT, CUSTOMER SAMPLES AND PICTURE TO OUR SUPPLIER FOR THEIR INVESTIGATION AND COMMENTS. A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS OF THE CONCERNED BATCH SHOWED NO ABNORMALITY WHICH COULD BE RELATED TO THE REPORTED ISSUE. RETAIN AND CUSTOMER SAMPLES WERE VISUALLY INSPECTED; NO BENT FRONT NEEDLE NOR ABNORMALITY RELATED TO THE REPORTED EVENT WAS FOUND. THE RIGIDITY OF THE NEEDLE TUBES WAS ALSO TESTED; ALL WERE WITHIN THE RANGE OF STANDARDS, MEANING THE NEEDLE PART OF THE PRODUCT CONCERNED IS STRONG ENOUGH TO MEET INTERNATIONAL STANDARDS. HOWEVER, IT MAY BE DEFORMED OR DAMAGED IF THE LOAD EXCEEDS THIS LIMIT. THE COMPLAINT COULD NOT BE DUPLICATED.

Description of Event or Problem · 1

CUSTOMER STATES ACTIVATED SAFETY AND NEEDLE BENT. THE SAFETY WAS ACTIVATED WITH THE THUMB. THE PHLEBOTOMIST DID NOT GET NEEDLE STICK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1120522	VACUETTE MULTIPLE USE DRAWING NEEDLE 22G X 1 1/4" BLACK, STERILE	CANNULA	FMI	GREINER BIO-ONE GMBH	450061	20G23C

Patients

Seq	Age	Sex	Outcome	Treatment
1