PAIN TRAY 89-8611

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 2016-06-01 for PAIN TRAY 89-8611 manufactured by Deroyal Industries, Inc..

Event Text Entries

[46268587] Investigation summary: an internal complaint ((b)(4)) was received regarding 5cc and 3cc syringes in finished good 89-8611 (pain tray). When filled, small black foreign objects could be seen floating in the syringes, which were intended to be used for injection. A sample was returned for evaluation and received may 9. An evaluation of the sample confirmed the reported issue. The syringes ((b)(4)) are supplied to deroyal by (b)(4). Therefore, a supplier corrective action request has been sent to (b)(4). 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


[46268588] The 5cc and 3cc syringes in the pack are filled with medication for injection, and on multiple occasions, there have been very small black foreign objects floating in the syringes. The doctor was unable to use the syringe when this happens, and a new one is pulled to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5


[50736034] Root cause: the syringes within the convenience kit are supplied to deroyal by (b)(4) therefore, a supplier corrective action request (scar) was issued to (b)(4). In its response, (b)(4) stated the male mold compresses the vulcanized rubber sheet into the female mold to form the piston tip. Another machine then punches each piston tip out of the sheet. During this punch process, loose rubber particles can be created. Corrective action: in its scar response, the supplier stated the plunger manufacturer has a mechanical shaking process to dislodge any particulate present and then water wash steps to remove these particulates. There is also additional incoming in-process inspection and final inspection processes to control the issue. Investigation summary: an internal complaint (b)(4) was received regarding 5cc and 3cc syringes in finished good 89-8611 (pain tray). When filled, small black foreign objects could be seen floating in the syringes, which were intended to be used for injection. A sample was returned for evaluation and received may 9. An evaluation of the sample confirmed the reported issue. The syringes (raw materials 5-20058 and 5-20060) are supplied to deroyal by (b)(4). A scar was issued to (b)(4) and a response has been received. In its response, the supplier indicated inventory was statistically sampled and no issues were found. The visual inspection sampling process has been increased for the requested issue. The work order for the finished good was reviewed for discrepancies that would have contributed to the reported issue. No discrepancies were identified. Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs after the implemented actions. Preventive action: in its scar response, (b)(4) stated a preventive action has not been taken. The investigation is complete at this time. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10


[50736035] The 5cc and 3cc syringes in the pack are filled with medication for injection, and on multiple occasions, there have been very small black foreign objects floating in the syringes. The doctor was unable to use the syringe when this happens, and a new one is pulled to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005011024-2016-00007
MDR Report Key5690890
Report SourceUSER FACILITY
Date Received2016-06-01
Date of Report2016-07-26
Date of Event2016-04-18
Date Mfgr Received2016-05-02
Date Added to Maude2016-06-01
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 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 NamePAIN TRAY
Generic NameNERVE BLOCK TRAY (KIT)
Product CodeOGJ
Date Received2016-06-01
Returned To Mfg2016-05-09
Catalog Number89-8611
Lot Number41809957
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 2016-06-01

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