MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-12-05 for SPINAL PAIN TRAY INTERVENTION 89-9753 manufactured by Deroyal Industries, Inc..
[130042321]
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.
Patient Sequence No: 1, Text Type: N, H10
[130042322]
When the syringe is used in tight spinal areas, the pressure would pop the extension set off, causing loss of medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2018-00012 |
| MDR Report Key | 8134107 |
| Report Source | USER FACILITY |
| Date Received | 2018-12-05 |
| Date of Report | 2018-12-05 |
| Date of Event | 2018-11-05 |
| Date Mfgr Received | 2018-11-05 |
| Date Added to Maude | 2018-12-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1501 EAST CENTRAL AVENUE |
| Manufacturer City | LAFOLLETTE TN 37766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINAL PAIN TRAY INTERVENTION |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2018-12-05 |
| Returned To Mfg | 2018-11-08 |
| Model Number | 89-9753 |
| Lot Number | 47830175 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 1501 EAST CENTRAL AVENUE LAFOLLETTE TN 37766 US 37766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-05 |