FDA Adverse Event Malfunction Summary report: N

IVT DISPOSABLE

MDR report key: 3150779 · Received June 6, 2013

Report

Report Number: 1416980-2013-14555
Event Type: Malfunction
Date Received: June 6, 2013
Date of Event: February 2, 2013
Report Date: May 14, 2013
Manufacturer: BAXTER HEALTHCARE - THETFORD
Product Code: LHI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NO
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE NOTED THAT THE BACKING PAPER WAS DETACHED FROM THE CLEAR BLISTER PACKAGING. IT WAS FURTHER NOTED THAT THERE WAS NOT A STRONG BOND BETWEEN THE BLISTER PACKAGING AND THE BACKING PAPER. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS OPENED TO ADDRESS THIS ISSUE. THE CAUSE WAS DETERMINED TO BE A MANUFACTURING DEFICIENCY. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHEN OPENING THE PACKAGING FOR A VIAL MATE RECONSTITUTION DEVICE, THE PAPER BACKING WAS "LOOSE" FROM THE BLISTER PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
250256	IVT DISPOSABLE	SET, I.V. FLUID TRANSFER	LHI	BAXTER HEALTHCARE - THETFORD		13G25VM01

Patients

Seq	Age	Sex	Outcome	Treatment
1