MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-04-22 for HIGH FLOW HEATED INSUFFLATOR TUBING (5BX) 0620030407 manufactured by Stryker Endoscopy Puerto Rico.
[1186557]
It was reported that there was a large hair in the packaging. Allegedly, it was laying in the center of the tubing.
Patient Sequence No: 1, Text Type: D, B5
[8280089]
Add'l info will be provided once investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648666-2009-00070 |
| MDR Report Key | 1429870 |
| Report Source | 04 |
| Date Received | 2009-04-22 |
| Date of Report | 2009-03-25 |
| Date of Event | 2009-03-25 |
| Date Mfgr Received | 2009-03-25 |
| Device Manufacturer Date | 2009-02-02 |
| Date Added to Maude | 2010-07-23 |
| 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 | NILA PATEL |
| Manufacturer Street | 5900 OPTICAL COURT |
| 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 IND. PARK |
| Manufacturer City | ARROYO PR 00615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00615 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH FLOW HEATED INSUFFLATOR TUBING (5BX) |
| Generic Name | TUBING |
| Product Code | NKC |
| Date Received | 2009-04-22 |
| Returned To Mfg | 2009-04-08 |
| Catalog Number | 0620030407 |
| Lot Number | 09033FE2 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2009-04-22 |