MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. SPINAL PAIN TRAY INTERVENTION; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Model Number	89-9753
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the syringe packaged in the deroyal convenience kit is supplied by (b)(4).In a supplier corrective action report (scar), (b)(4) stated it was unable to determine a root cause for the reported event.The supplier reviewed the manufacturing process and returned samples, and all parts were qualified.Corrective action: in its scar response, (b)(4) indicated the injection molding inspector was retrained on the syringe process inspection specification, with emphasis on paying attention to luer-lock matching detection.Investigation summary: an internal complaint ((b)(4)) was received indicating that a syringe contained in a convenience kit (part number 89-753, lot 47830175) failed during use.The end user reported that when the syringe was used in tight spinal areas, the pressure would cause the extension set to pop off, resulting in a loss of medication.A sample was returned november 8, 2018 to deroyal.These were forwarded to the supplier november 9, 2018 for evaluation.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 was reviewed, and raw material 5-20060 was identified as the affected kit component.This part is supplied to deroyal by (b)(4).The scar and supplier notification letter logs were reviewed for the period of 2016 to present for similar complaints.Previous scars were found for similar non-conformances.Therefore, a scar was issued to (b)(4).A response was received and accepted by deroyal's complaint investigator.Deroyal will continue to monitor post market feedback and will recognize in the future if this issue reoccurs.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
When the syringe is used in tight spinal areas, the pressure would pop the extension set off, causing loss of medication.

• Brand Name: SPINAL PAIN TRAY INTERVENTION
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 8134107
• Report Number: 3005011024-2018-00012
• Device Sequence Number: 2166146
• Product Code: KDD
• UDI-Device Identifier: 00749756936057
• UDI-Public: 00749756936057
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 89-9753
• Device Lot Number: 47830175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1