MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-29 for VSP SYSTEM VSPO manufactured by 3d Systems.
[53409232]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[53409233]
Vsp product patient specific deliverables for the incorrect patient were shipped to the wrong location and were incorrectly labeled. Deliverables for work order (wo) # (b)(4) were shipped to the incorrect location on 07/27/2016. The parts were sent to the shipping address for wo# (b)(4). Deliverables for wo# (b)(4) contained part package labels reflecting the case information for wo# (b)(4). The vspo case bundle for wo# (b)(4) was intended to ship on 07/27/2016, but was to be held because the billing documentation had not yet been completed. The nonconformance was identified on 07/28/2016 when billing documentation was being created for wo# (b)(4) and the internal patient database entry for that case already had a (b)(6) tracking number (the tracking number stated the package had been delivered). Quality personnel then determined deliverables for a different case (wo#(b)(4)) was sent using the wo# (b)(4) shipping label by looking at the shipping label reference stickers placed into every device history record after shipment for cases that sent 07/27/2016 (these stickers list the tracking number for that shipping label). Upon identification that deliverables for wo# (b)(4) were sent to the incorrect location, the recipient of incorrect parts was immediately notified by quality personnel and agreed to destroy the incorrect parts. The correct deliverables for wo# (b)(4) were shipped to the mr. (b)(6) on 07/28/2016 for usage in surgery on (b)(6) 2016. Also upon identification that deliverable for wo# (b)(4) were sent to the incorrect location, the intended recipient of parts for wo# (b)(4) was immediately notified by vspo personnel. Vspo personnel coordinated a saturday (07/30/2016) delivery of duplicate parts to the sales representative as well as a monday (08/01/2016) delivery of duplicate parts to the surgeon (dr. (b)(6)) for surgery on (b)(6) 2016. Both set of duplicate parts were manufactured on 07/29/2016 and shipped on 07/29/2016. There were no effects to the patients and surgeries were performed as planned. However, if the issue had not been identified prior to the parts being received by the operating physician, there is a possibility the incorrect parts could have made it to surgery before being identified as incorrect. The root cause was determined to be a mix up of billing documentation, case reports, product labels, and shipping labels for the two mentioned wo numbers. The mix up was not caught at final qc inspection or in shipping. 3d systems initiated a corrective and preventive action (capa) to further address the issue and prevent reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1724955-2016-00003 |
| MDR Report Key | 5912067 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-29 |
| Date of Report | 2016-07-28 |
| Date of Event | 2016-07-27 |
| Date Mfgr Received | 2016-07-28 |
| Device Manufacturer Date | 2016-07-27 |
| Date Added to Maude | 2016-08-29 |
| 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 | MR. SCOTT BREWER |
| Manufacturer Street | 5381 SOUTH ALKIRE CIRCLE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7206431001 |
| Manufacturer G1 | 3D SYSTEMS |
| Manufacturer Street | 5381 SOUTH ALKIRE CIRCLE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80127 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VSP SYSTEM |
| Generic Name | VSP ORTHOGNATHICS |
| Product Code | DZJ |
| Date Received | 2016-08-29 |
| Model Number | VSPO |
| Lot Number | 74484 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3D SYSTEMS |
| Manufacturer Address | 5381 SOUTH ALKIRE CIRCLE LITTLETON CO 80127 US 80127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-29 |