MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for 30G HYDRODISSECTION CAN.MOD. G-34270 manufactured by Aspen Surgical Products, Caledonia.
[112563775]
Aspen surgical received a report from the distributor indicating that a 30g cannula was found with an incomplete seal on the blister container. A sample was provided for evaluation along with manufacturing lot number. A review of the sample confirmed the issue as indicated from the distributor. Analysis of the finished good lot number was reviewed. No non-conformance's were noted during the manufacturing process. The blister container appeared to be fully formed and showed no signs of damage. The seal weld at the peel open flap however, revealed signs of an incomplete seal. Based on the shape of the seal weld, the inner pouch was incidentally sealed in the outer pouch causing it to be incomplete. Therefore, the reported issue was the result of a loading error and a root cause for the incomplete seal is attributed to operator error. No further action is required as aspen surgical no longer manufactures or packages this part number.
Patient Sequence No: 1, Text Type: N, H10
[112563776]
Aspen surgical received a report from the distributor indicating that a 30g cannula was found with an incomplete seal on the blister container. The item was not in use and no injury/death was reported. This report was filed in our complaint handling system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2018-00077 |
| MDR Report Key | 7642470 |
| Date Received | 2018-06-27 |
| Date of Report | 2018-05-28 |
| Date of Event | 2018-05-28 |
| Date Mfgr Received | 2018-05-28 |
| Device Manufacturer Date | 2017-06-12 |
| Date Added to Maude | 2018-06-27 |
| 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 | 30G HYDRODISSECTION CAN.MOD. |
| Generic Name | OPHTHALMIC CANNULA |
| Product Code | HMX |
| Date Received | 2018-06-27 |
| Model Number | G-34270 |
| Lot Number | 138466 |
| 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 | 2018-06-27 |