N/A CB5LT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-02-22 for N/A CB5LT manufactured by .

Event Text Entries

[14886252] It was reported that while in inventory at the user facility, it was noticed that "there is no tip protector and the trocar is puncturing a hole in the packaging. " the device was not used.
Patient Sequence No: 1, Text Type: D, B5


[15274665] Stryker sustainability solutions (sss) resterilized the complaint device through our open-but-unused process. The complaint device was returned to sss in its original sealed packaging. The package was noticed to possess indentions in the proximity of the device tip. It was confirmed that the sterile barrier had been breached by the device tip. It was confirmed that these devices are shipped from the om without a tip protector; instead, the device is packaged in a pouch configuration that appears to prevent indentions in the packaging without the use of a tip protector. The packaging will be changed to use the same packaging requirements currently validated through the full process trocar product line in sss's (b)(4) location. The reported event is not occurring more frequently or with greater severity than is usual for the device.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2090040-2012-00006
MDR Report Key2464560
Report Source05,06,07
Date Received2012-02-22
Date of Report2012-01-27
Date Mfgr Received2012-01-27
Device Manufacturer Date2011-12-13
Date Added to Maude2012-08-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. MOIRA BARTON-VARTY
Manufacturer Street1810 W DRAKE DR
Manufacturer CityTEMPE AZ 85283
Manufacturer CountryUS
Manufacturer Postal85283
Manufacturer Phone4807635300
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameN/A
Generic NameGCJ
Product CodeOEX
Date Received2012-02-22
Returned To Mfg2012-02-02
Model NumberCB5LT
Catalog NumberCB5LT
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2012-02-22

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