MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-20 for NRG TRANSSEPTAL NEEDLE NRG-E-HF-71-C0 manufactured by Baylis Medical Company Inc..
[114564502]
There was no patient impact or adverse event. The complaint was detected by the distributor during incoming inspection prior to distribution to customers or use in patient. Any relevant information as a result of the investigation will be provided in a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[114564503]
A report was received from a distributor stating that a defect was observed in the sterile packaging (nylon side) of the nrg transseptal needle during their incoming inspection of the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710452-2018-00028 |
| MDR Report Key | 7706165 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-07-20 |
| Date of Report | 2018-07-20 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-06-21 |
| Date Added to Maude | 2018-07-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. MEGHAL KHAKHAR |
| Manufacturer Street | 2775 MATHESON BLVD. EEAST |
| Manufacturer City | MISSISSAUGA, ONTARIO L4W 4P7 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4W 4P7 |
| Manufacturer G1 | BAYLIS MEDICAL COMPANY INC. |
| Manufacturer Street | 2775 MATHESON BLVD. EAST |
| Manufacturer City | MISSISSAUGA, ONTARIO L4W 4P7 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L4W 4P7 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NRG TRANSSEPTAL NEEDLE |
| Generic Name | RF TRANSSEPTAL NEEDLE |
| Product Code | DXF |
| Date Received | 2018-07-20 |
| Model Number | NRG-E-HF-71-C0 |
| Catalog Number | NRG-E-HF-71-C0 |
| Lot Number | NGFC040518 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYLIS MEDICAL COMPANY INC. |
| Manufacturer Address | 5959 TRANS-CANADA HIGHWAY MONTREAL, QUEBEC H4T 1A1 CA H4T 1A1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-20 |