C-SECTION TRACEPACK 89-9338

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-11 for C-SECTION TRACEPACK 89-9338 manufactured by Deroyal Industries, Inc..

Event Text Entries

[134371403] Investigation summary: an internal complaint ((b)(4)) was received for a convenience kit (finished good 89-9338, lot 47970039) that contained a cautery pencil that malfunctioned during use. The pencil reportedly had an electrical arc. Samples were returned for evaluation and forwarded to the component supplier for review. The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported issue. No discrepancies were identified. The bill of materials for the finished good kit was reviewed and the affected component was identified as a hand control pencil with a coated blade (raw material (b)(4)). This pencil is supplied to deroyal by (b)(4). The 2016-2018 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints. Similar non-conformances were found and a scar was issued to (b)(4). As of the date of this report, a response has not been received. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10


[134371404] A convenience kit contained a cautery pencil that malfunctioned during use and reportedly had an electrical arc.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005011024-2018-00017
MDR Report Key8239717
Report SourceUSER FACILITY
Date Received2019-01-11
Date of Report2019-02-27
Date of Event2018-12-12
Date Mfgr Received2018-12-12
Date Added to Maude2019-01-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSARAH BENNETT
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8653626112
Manufacturer G1DEROYAL INDUSTRIES, INC.
Manufacturer Street1501 EAST CENTRAL AVENUE
Manufacturer CityLAFOLLETTE TN 37766
Manufacturer CountryUS
Manufacturer Postal Code37766
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameC-SECTION TRACEPACK
Generic NameDISPOSABLE SURGICAL INSTRUMENT KIT
Product CodeKDD
Date Received2019-01-11
Returned To Mfg2018-12-27
Model Number89-9338
Lot Number47970039
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEROYAL INDUSTRIES, INC.
Manufacturer Address1501 EAST CENTRAL AVENUE LAFOLLETTE TN 37766 US 37766


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-11

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