EXPECT

Report

Report Number: 3005099803-2011-02721
Event Type: Malfunction
Date Received: August 4, 2011
Date of Event: July 13, 2011
Report Date: July 13, 2011
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: ODG
PMA / PMN Number: K100712
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

RECALL #Z -3215-11. (B)(4).

Additional Manufacturer Narrative · 1

ACCORDING TO THE COMPLAINANT, THE REPORTED DEVICE CONTAINER HAS BEEN RETAINED, AND IS NOT AVAILABLE FOR RETURN. AN EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT ASPIRATION NEEDLE DEVICE WAS FOUND TO HAVE A DIFFERENT LABEL ON THE OUTSIDE OF THE OUTER BOX, THAN WHAT WAS PACKAGED INSIDE. ACCORDING TO THE COMPLAINANT, THE INNER PACKAGE WAS CORRECTLY LABELED AS A 25GA EXPECT ASPIRATION NEEDLE DEVICE. THE OUTER BOX, WHICH HOLD THE INDIVIDUAL DEVICES HAD A LABEL FOR A 22GA EXPECT NEEDLE DEVICE. AS THE INNER LABELS ARE CORRECT, THE HOSPITAL WILL KEEP THE PRODUCT FOR LATER USE. NO PROCEDURE, OR PATIENT WAS INVOLVED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT ASPIRATION NEEDLE DEVICE WAS FOUND TO HAVE A DIFFERENT LABEL ON THE OUTSIDE OF THE OUTER BOX, THAN WHAT WAS PACKAGED INSIDE. ACCORDING TO THE COMPLAINANT, THE INNER PACKAGE WAS CORRECTLY LABELED AS A 25GA EXPECT ASPIRATION NEEDLE DEVICE. THE OUTER BOX, WHICH HOLD THE INDIVIDUAL DEVICES HAD A LABEL FOR A 22GA EXPECT NEEDLE DEVICE. AS THE INNER LABELS ARE CORRECT, THE HOSPITAL WILL KEEP THE PRODUCT FOR LATER USE. NO PROCEDURE, OR PATIENT WAS INVOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EXPECT	KIT, NEEDLE, BIOPSY	ODG	BOSTON SCIENTIFIC - MARLBOROUGH	M00550020	13615651C1

Patients

Seq	Age	Sex	Outcome	Treatment
1