MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-10 for RICHARD ALLAN MODERN REG TIP PEN - STERILE 2750 manufactured by Aspen Surgical Products, Caledonia.
[114012883]
Aspen surgical received a report from the distributor indicating that product was found with a defective seal. The actual device was not returned for evaluation. The manufacturing lot numbers along with photographic evidence was provided for review. A review of the photos confirmed the issue from the distributor. Analysis of the finished good lot number was reviewed. No non-conformance's were noted during the manufacturing process. The ifu, 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. Due to no sample being returned, a root cause and investigation could not be performed. However, if a sample becomes available and any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report. Based on this information, no further action is required. .
Patient Sequence No: 1, Text Type: N, H10
[114012884]
Aspen surgical received a report from the distributor indicating that richard-allan regular tip pen was found with damaged seals. The item was not in use. No injury/death was reported. This report was filed in our complaint handling system for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2018-00079 |
| MDR Report Key | 7673812 |
| Date Received | 2018-07-10 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-06-14 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2017-04-11 |
| Date Added to Maude | 2018-07-10 |
| 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 | RICHARD ALLAN MODERN REG TIP PEN - STERILE |
| Generic Name | MARKING PEN |
| Product Code | FZZ |
| Date Received | 2018-07-10 |
| Model Number | 2750 |
| Lot Number | 131244 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-07-10 |