FDA Adverse Event Injury Summary report: N

BD PLASTIPAK SYRINGE WITH NEEDLE 26G X 3/8"

MDR report key: 4860062 · Received June 16, 2015

Report

Report Number: 2243072-2015-00110
Event Type: Injury
Date Received: June 16, 2015
Date of Event: May 30, 2015
Report Date: June 16, 2015
Manufacturer: BD
Product Code: FMF
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

RESULTS: THREE SEALED, UNUSED SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL ANALYSIS REVEALED THAT THE BLISTER PACKAGES WERE COMPLETELY SEALED AND THAT THERE WAS NO PERFORATION IN THE FILM OR IN THE PAPER OF THE BLISTERS. A SEALING RESISTANCE TEST WAS PERFORMED AND THE SEALING CORD OF THE BLISTER PACKAGES WAS CHECKED AND THE RESULTS WERE WITHIN MANUFACTURING SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD AND STERILITY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 1412077. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS THE RETURNED SAMPLES MET MANUFACTURING SPECIFICATIONS.

Additional Manufacturer Narrative · 1

A SAMPLE IS AVAILABLE FOR EVAL. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A COMBINED VITRECTOMY AND CATARACT SURGERY, A PT EXPERIENCED OCULAR INFLAMMATION AND CORNEAL EDEMA. A BD PLASTIPAK SYRINGE WITH NEEDLE WAS USED DURING THIS PROCEDURE. AS A PRECAUTION THE DEVICE WAS PUT IN QUARANTINE, CORNEAL SAMPLES WERE TAKEN, AND THE PT WAS TREATED WITH ANTIBIOTICS. THE PT ALSO HAD ROUTINE POST OPERATIVE MONITORING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
392981	BD PLASTIPAK SYRINGE WITH NEEDLE 26G X 3/8"	HYPODERMIC SYRINGE	FMF	BD		1412077

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention