VISTEC SPG 4X4 NON ST 10S 16PLY 7148

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-08 for VISTEC SPG 4X4 NON ST 10S 16PLY 7148 manufactured by Covidien.

Event Text Entries

[42944747] Submit date:04/08/2016. An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


[42944748] It was reported to covidien on (b)(6) 2016 that the customer had an issue with a: gauze sponge. The customer reported: they received shorted packs of comp# (b)(4). Two kits had packs of 9ea of this gauze, instead of the 10 ea that should be in each pk. This was reported on the plastic minor pack. Neither patient injury nor medical intervention has been reported.
Patient Sequence No: 1, Text Type: D, B5


[55588846] The device history record (dhr) for lot 15j196862x indicates that there were no defects found in (b)(4) samples per machine inspected from the lot. There were no samples submitted with this complaint therefore the reported condition could not be confirmed. The complaint shall be reopened if a sample is received. A possible root cause may be attributed to the scale challenge for weight count if it was not set up correctly on autobanders, added variables could have contributed to a weight discrepancy for the scale on the autobanders. Product originates from the manufacturing facility and then goes to another source to be used such as a kit packing facility. It is also possible that sponges could have been lost during that process. Prior to a lot's release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan. Inspectors routinely examine a statistical sample both physically and visually. Counts are performed as part of the inspection criteria for in process. This evaluation is performed at a tightened sample size for miscounts. The lot met all defined acceptance requirements and was released. A formal corrective and preventative action (capa) was initiated to address the miscount complaints for vistec products. During this capa, the off line banding equipment was discontinued. A reversal of the autobander trays was performed to tighten the bands. An additional capa has been opened to optimize the autobander process in which the product specification has been updated to include this complaint type and identify the occurrence. A rotation of stacked sponges will be removed from the process and validation activities will be performed. This capa is currently in the implementation stage. This information will be utilized for trending purposes to determine the need for additional corrective actions. The production department will be notified of this incident with a copy of this complaint response. Finished goods testing is currently being performed at a heighten level for products packaged using banded 10 units for miscount. This heightened testing is performed to ensure containment for the reported condition. Sample availability was requested on (b)(6). On (b)(6), it was confirmed that sample is not available because the customer discarded the sample.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1018120-2016-00057
MDR Report Key5563560
Date Received2016-04-08
Date of Report2016-04-07
Date Mfgr Received2016-09-14
Date Added to Maude2016-04-08
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 FDA3
Event Location3
Manufacturer ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN
Manufacturer Street1430 MARVIN GRIFFIN ROAD
Manufacturer CityAUGUSTA GA 30913
Manufacturer CountryUS
Manufacturer Postal Code30913
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVISTEC SPG 4X4 NON ST 10S 16PLY
Generic NameGAUZE SPONGE
Product CodeEFQ
Date Received2016-04-08
Model Number7148
Catalog Number7148
Lot NumberASKU
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address1430 MARVIN GRIFFIN ROAD AUGUSTA GA 30906 US 30906


Patients

Patient NumberTreatmentOutcomeDate
10 2016-04-08

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