CITRATE TUBE

MDR report key: 7059119 · Received November 27, 2017

Report

Report Number: 9617023-2017-00130
Event Type: Malfunction
Date Received: November 27, 2017
Date of Event: May 25, 2016
Report Date: January 25, 2018
Manufacturer: BECTON, DICKINSON AND COMPANY (BD)
Product Code: JKA
PMA / PMN Number: K013971
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT DATE OF EVENT. THE CORRECT DATE OF EVENT IS (B)(6) 2016.

Additional Manufacturer Narrative · 1

DATE OF EVENT UNKNOWN. DATE OF NOTIFICATION HAS BEEN USED IN THIS FIELD. (B)(6). RESULTS: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKAGE FROM THE CITRATE TUBE WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. NO OBJECTIVE EVIDENCE WAS PROVIDED AND FUNCTION TESTING OF RETAINED SAMPLES FROM THIS LOT NUMBER DID NOT CONFIRM THE DEFECT.

Additional Manufacturer Narrative · 1

THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT 510K NUMBER. THE 510K OF THIS DEVICE IS K013971.

Description of Event or Problem · 1

IT WAS REPORTED THAT SEVERAL TUBES SAMPLES AND WHEN INSERTING CITRATE TUBE BLOOD LEAKED ON THE PATIENT'S ARM. TUBE WAS REMOVED BUT BROKE IN 2 PIECES (ONE PIECE REMAINED INTO THE HOLDER). BLOOD EXPOSURE BUT NO WOUND AND NO CONSEQUENCES. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
838862	CITRATE TUBE	CITRATE TUBE	JKA	BECTON, DICKINSON AND COMPANY (BD)		5090310

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other