MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-01-10 for HIGH FLOW HEATED INSUFFLATOR TUBING (5BX) 0620030407 manufactured by Stryker Endoscopy Puerto Rico.
[16044824]
It was reported by a company representative that there was a foreign material inside the sterile packaging. It was further reported that there was no pt involvement.
Patient Sequence No: 1, Text Type: D, B5
[16192128]
Additional info will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648666-2012-00007 |
| MDR Report Key | 2435939 |
| Report Source | 07 |
| Date Received | 2012-01-10 |
| Date of Report | 2011-12-19 |
| Date of Event | 2011-12-19 |
| Date Mfgr Received | 2011-12-19 |
| Date Added to Maude | 2012-03-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUNNY OFFORJEBE |
| Manufacturer Street | 5900 OPTICAL CT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY PUERTO RICO |
| Manufacturer Street | HWY #3, KM. 130.2 LAS PALMAS INDUSTRIAL PARK |
| Manufacturer City | ARROYO PR 00615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH FLOW HEATED INSUFFLATOR TUBING (5BX) |
| Generic Name | INSUFFLATOR TUBING |
| Product Code | NKC |
| Date Received | 2012-01-10 |
| Returned To Mfg | 2011-12-27 |
| Catalog Number | 0620030407 |
| Lot Number | 11307FE2 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY PUERTO RICO |
| Manufacturer Address | ARROYO PR 00615 US 00615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-10 |