FDA Adverse Event Malfunction Summary report: N

BD SEDI-40

MDR report key: 12163194 · Received July 13, 2021

Report

Report Number: 2243072-2021-01860
Event Type: Malfunction
Date Received: July 13, 2021
Date of Event: June 23, 2021
Report Date: June 28, 2021
Manufacturer: BECTON DICKINSON
Product Code: JKA
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PL
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS ELITECH. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: INSTRUMENT SEDI 40 00120 WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH RESPECT TO THE REPORTED DEFECT ¿ BROKEN COVER. THE INSTRUMENT WAS EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND A DOWEL PIN WAS FOUND TO BE MISSING FROM THE TUBE COVER, THE COVER ITSELF WAS DAMAGED, AND THE FAN WAS FOUND TO BE NOISY. THE COVER WAS REPLACED ALONG WITH THE DOWEL PIN AND A NEW FAN WAS INSERTED. NO FURTHER DEFECTS WERE OBSERVED AFTER REPAIR AS ALL PRODUCT SPECIFICATIONS WERE MET. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem · 1

IT WAS REPORTED WHEN USING THE BD SEDI-40, THE DEVICE EXPERIENCED HARDWARE / SOFTWARE MALFUNCTION FOR ESR INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: BROKEN COVER OF SEDI40.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1056228	BD SEDI-40	BLOOD SPECIMEN COLLECTION DEVICE	JKA	BECTON DICKINSON		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1