MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2010-05-20 for INSUFFLATION BULB FILTER, QTY 10 30210 manufactured by Welch Allyn, Inc..
[1508811]
The complainant at (b)(6) hosp, (b)(6), was using the insufflation bulb filter when fluid leaked through the filter into the insufflation bulb causing contamination. That specific filter was disposed of. Filters from the remaining (unused) stock supply were gathered and returned to welch allyn for eval. The complainant indicated that there was no pt involvement. This filter is used with product code fcy bulb, inflation, for endoscope.
Patient Sequence No: 1, Text Type: D, B5
[8648914]
Method - the filter was disposed of but the complainant gathered filters from remaining (unused) stock and returned these samples to welch allyn for eval. The filters were rec'd on april 28th, 2010 and the eval is underway but is not yet complete. A follow-up report will be filed when the eval is finished.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2010-00003 |
| MDR Report Key | 1699537 |
| Report Source | 00,01,05,06 |
| Date Received | 2010-05-20 |
| Date of Report | 2010-01-24 |
| Date of Event | 2010-01-24 |
| Date Mfgr Received | 2010-01-24 |
| Date Added to Maude | 2010-11-05 |
| 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 | PEARLEY BHAMBRI, SR MGR |
| Manufacturer Street | 4341 STATE ST. RD. |
| Manufacturer City | SKANEATELES FALLS NY 13153 |
| Manufacturer Country | US |
| Manufacturer Postal | 13153 |
| Manufacturer Phone | 3156852568 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSUFFLATION BULB FILTER, QTY 10 |
| Product Code | FCY |
| Date Received | 2010-05-20 |
| Model Number | 30210 |
| Catalog Number | 30210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-20 |