MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for DR FOG TREATED SPONGE, STERILE DF-3120 manufactured by Aspen Surgical Products, Caledonia.
[131775758]
Aspen surgical received a report from the distributor indicating that product was found in the seal of the pouch. The actual device was returned for evaluation. The manufacturing lot numbers along with photographic evidence was provided for review. The lot numbers associated with the report are as follows: 156562, 158682, and 160108. The distributor indicated that the defects were found during incoming inspection. A review of the samples and photos confirmed the issue from the distributor. Analysis of the finished good lot numbers were reviewed. No non-conformance's were noted during the manufacturing process. According to the manufacturing process, these parts are manually loaded into recessed pockets on a packaging machine per specified work instructions. If incorrectly loaded or not orientated properly, the product interferes with the sealing process. Therefore a likely root cause for the parts in the seal may be attributed to an operator error. The ifu which is received with the product, along with the pouch label, identifies this failure mode with the symbol "do not use if package is damaged". This indicates that the device should not be used if the products sterile barrier system or its packaging is compromised. Additionally, 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
[131775759]
Aspen surgical received a report from the distributor indicating that dr fog sponge was found with seal issues. The item was not in use. No injury/death was reported. This report was filed in our complaint handling system for multiple lot numbers. The complaint references for these lot numbers are as follows: (b)(4) - lot 156562 ((b)(4)); (b)(4) - lot 158682 ((b)(4)); (b)(4) - lot 160108 ((b)(4)).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2018-00127 |
| MDR Report Key | 8160825 |
| Date Received | 2018-12-13 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-10-12 |
| Date Mfgr Received | 2018-11-15 |
| Date Added to Maude | 2018-12-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | DR FOG TREATED SPONGE, STERILE |
| Generic Name | ANTI-FOG |
| Product Code | OCT |
| Date Received | 2018-12-13 |
| Model Number | DF-3120 |
| Lot Number | SEE ABOVE |
| 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 | 2018-12-13 |