MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for MURANAKA SURGICAL MARKING PEN, STERILE MMI02730PBX manufactured by Aspen Surgical Products, Caledonia.
[138562147]
Aspen surgical received a report from the distributor indicating that a marking pen was discovered with sheet labels in the seal of the pouch. The actual device was returned for evaluation. The manufacturing lot number was also provided for review. A review of the sample confirmed the issue discovered by the distributor. Analysis of the finished good lot number was reviewed. No non-conformance's for this issue were noted during the manufacturing process. This product is packaged on a machine where rulers and labels are auto-loaded and the markers are manually loaded into the recess pockets of the form, fill, and seal machine. This machine can lead to mis-aligning of material in the pockets and the operator checks for alignment (seated) within the pockets. Therefore, the root cause for the sealing error are attributed to operator error. Production supervisors and operations were notified of this issue during the daily update meetings. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[138562148]
Aspen surgical received a report from the distributor indicating that a surgical marking pen was discovered with a sealing defect. The item was not in use. No injury/death was reported. This report was filed in our complaint handling system as number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2019-00015 |
| MDR Report Key | 8349468 |
| Date Received | 2019-02-19 |
| Date of Report | 2019-01-24 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2019-01-24 |
| Device Manufacturer Date | 2018-04-18 |
| Date Added to Maude | 2019-02-19 |
| 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. JORDAN HACKERT |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6165367508 |
| Manufacturer G1 | SAME AS ABOVE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MURANAKA SURGICAL MARKING PEN, STERILE |
| Generic Name | MARKING PEN |
| Product Code | FZZ |
| Date Received | 2019-02-19 |
| Model Number | MMI02730PBX |
| Lot Number | 161469 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-19 |