FDA Adverse Event Malfunction Summary report: N

LEVEL 1 HOTLINE DISPOSABLE ADMINISTRATION SETS

MDR report key: 9960346 · Received April 14, 2020

Report

Report Number: 3012307300-2020-02988
Event Type: Malfunction
Date Received: April 14, 2020
Date of Event: March 18, 2020
Report Date: May 27, 2020
Manufacturer: SMITHS MEDICAL ASD; INC.
Product Code: LGZ
UDI-DI: 30695085407007
PMA / PMN Number: K911383
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

ONE LEVEL 1 HOTLINE DISPOSABLES WAS RETURNED FOR ANALYSIS. THE SAMPLE CONSIST OF THE PRODUCT FROM P/N L-70; L/N: 3850052, 3898249 AND THE RETURNED SAMPLE WAS RECEIVED WITHOUT THE ORIGINAL OPEN PACKAGING. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12" TO 24" UNDER NORMAL CONDITIONS OF ILLUMINATION AND THE SAMPLE PRESENTS BROKEN LUER. THE CUSTOMER'S REPORTED PROBLEM WAS CONFIRMED. HOWEVER, ACCORDING TO THE INVESTIGATION A REVIEW OF THE LEAK TESTING PERFORMED WAS CONDUCTED IN ORDER TO VERIFY THAT WAS PROPERLY PERFORMED; NO DISCREPANCIES WERE DETECTED DURING THE TESTING. AN AUDIT OF THE FINAL VISUAL INSPECTION PROCESS IN ORDER TO VERIFY WAS 100% INSPECTION; NO DISCREPANCIES WERE OBSERVED. ACCORDING TO THE INVESTIGATION THE MOST PROBABLE ROOT CAUSES WAS THAT THE FEMALE LUER BECAME DAMAGED AFTER THE PRODUCT LEFT SHM FACILITIES. AS PREVENTIVE ACTION: THE NOTIFICATION WAS PERFORMED PER PREVIOUS COMPLAINT. THE PROBLEM SOURCE OF THE REPORTED PROBLEM IS UNKNOWN.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED INDICATING THAT CRACK WAS FOUND ON A SMITHS MEDICAL LEVEL 1® HOTLINE® DISPOSABLE ADMINISTRATION SET WHICH CAUSED FLUID LEAK. THERE WAS NO REPORTED PATIENT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
420791	LEVEL 1 HOTLINE DISPOSABLE ADMINISTRATION SETS	WARMER, THERMAL, INFUSION FLUID	LGZ	SMITHS MEDICAL ASD; INC.	L-70		30695085407007

Patients

Seq	Age	Sex	Outcome	Treatment
1