FDA Adverse Event Malfunction Summary report: N

CONTROL PLASMA P

MDR report key: 11574856 · Received March 26, 2021

Report

Report Number: 9610806-2021-00034
Event Type: Malfunction
Date Received: March 26, 2021
Date of Event: March 1, 2021
Report Date: March 26, 2021
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Product Code: GGC
UDI-DI: 00842768011580
PMA / PMN Number: K042209
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. NO OTHER ISSUES WITH ANY OTHER CONTROL PLASMA P BOTTLES WERE REPORTED AT THIS SITE. THE CUSTOMER INDICATED THAT A SHIPPING OR HANDLING ISSUE MAY HAVE OCCURRED AND THE BOX MAY HAVE BEEN DROPPED. GLASS PIECES WERE ALSO REPORTED TO BE FOUND IN THE BOX. SIEMENS REVIEWED THE MANUFACTURING ORDER DOCUMENTS FOR CONTROL PLASMA P. THERE WAS NO INDICATION FOR A SYSTEMATIC FAILURE OF PROCESSES OR ANY MATERIAL ISSUES. CUSTOMER HANDLING, TRANSPORT, STORAGE OR PACKAGING CANNOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE EVENT. THE CAUSE OF THE EVENT IS UNKNOWN. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem · 1

THE CUSTOMER CUT THEIR THUMB DUE TO A CONTROL PLASMA P BOTTLE THAT BROKE DURING RECONSTITUTION. THE GLASS OF THE BOTTLE CUT THEIR THUMB AS THEY WERE OPENING THE BOTTLE. THE CUT REQUIRED ANTISEPTIC AND A BANDAGE. THE CUSTOMER HAS FOLLOWED THE SITE'S EXPOSURE PROTOCOLS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
475445	CONTROL PLASMA P	CONTROL PLASMA P	GGC	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH	CONTROL PLASMA P	556719	00842768011580

Patients

Seq	Age	Sex	Outcome	Treatment
1