FDA Adverse Event Malfunction Summary report: N

NON-VENTED HIGH-VOLUME INLET

MDR report key: 8823995 · Received July 24, 2019

Report

Report Number: 1416980-2019-03988
Event Type: Malfunction
Date Received: July 24, 2019
Report Date: July 24, 2019
Manufacturer: BAXTER HEALTHCARE - ROUND LAKE
Product Code: LHI
UDI-DI: 00085412475783
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

LOT NUMBER - 801976 AND 802407. TWO SINGLE-USE DEVICES WERE RECEIVED FOR EVALUATION. FOR THE FIRST SAMPLE, VISUAL INSPECTION REVEALED LOOSE PARTICULATE MATTER ON THE OUTSIDE OF THE TUBING SURFACE OF THE UNOPENED SAMPLE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A MANUFACTURING ISSUE. FOR THE SECOND SAMPLE, VISUAL INSPECTION WAS PERFORMED AND NOTED A LOOSE PARTICLE INSIDE THE PACKAGING, NOT TOUCHING THE PRODUCT. THE HAIR-LIKE PARTICLE WAS EXAMINED USING POLARIZED LIGHT MICROSCOPY (PLM) AND VERIFIED THE PARTICULATE MATTER TO BE A PIECE OF HUMAN HAIR. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A MANUFACTURING ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF EITHER LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS. IT WAS REPORTED THAT TWO (2) NON-VENTED HIGH-VOLUME INLETS HAD PARTICULATE MATTER IN THE PACKAGE. ONE OF THE DEVICES HAD DARK SPOTS IN THE PACKAGING, AND ONE DEVICE HAD A HAIR IN THE PACKAGE. BOTH EVENTS OCCURRED BEFORE USE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
618615	NON-VENTED HIGH-VOLUME INLET	SET, I.V. FLUID TRANSFER	LHI	BAXTER HEALTHCARE - ROUND LAKE	NA	SEE H10	00085412475783

Patients

Seq	Age	Sex	Outcome	Treatment
1