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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. PAIN TRAY NERVE BLOCK TRAY (KIT)

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DEROYAL INDUSTRIES, INC. PAIN TRAY NERVE BLOCK TRAY (KIT) Back to Search Results
Catalog Number 89-8611
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2016
Event Type  Malfunction  
Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received regarding 5cc and 3cc syringes in finished good (b)(4) (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. (b)(4). The investigation is ongoing at this time. When new and critical information is received, this report will be updated.

 
Event Description

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.

 
Manufacturer Narrative

Root cause: the syringes within the convenience kit are supplied to deroyal by (b)(4) inc. 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 (b)(4) (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 (b)(4)) 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.

 
Event Description

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.

 
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Brand NamePAIN TRAY
Type of DeviceNERVE BLOCK TRAY (KIT)
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
1501 east central avenue
lafollette TN 37766
Manufacturer (Section G)
DEROYAL INDUSTRIES, INC.
1501 east central avenue
lafollette TN 37766
Manufacturer Contact
sarah bennett
200 debusk lane
powell, TN 37849
8653626112
MDR Report Key5690886
MDR Text Key47522183
Report Number3005011024-2016-00006
Device Sequence Number1
Product Code OGJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 07/26/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/01/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-8611
Device LOT Number41450139
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/09/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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