MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-06-29 for PORTEX? MINI-TRACH? II - NON SELDINGER KIT 100/461/000 manufactured by Smiths Medical Asd; Inc..
[112849516]
Patient Sequence No: 1, Text Type: N, H10
[112849517]
Information was received indicating that following puncture of the patient, the saline filled syringe to a smiths medical mini-trach ii seldinger 4. 0mm cricothyroidotomy kit, could not be pulled back. It was noted that the needle had been clogged but had initially sucked air following attachment of the syringe. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-02525 |
| MDR Report Key | 7652635 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-06-29 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-07-13 |
| Device Manufacturer Date | 2017-11-13 |
| Date Added to Maude | 2018-06-29 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | HYTHE, KENT CT216JL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CT21 6JL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX? MINI-TRACH? II - NON SELDINGER KIT |
| Generic Name | CRICOTHYROTOMY KIT |
| Product Code | OGP |
| Date Received | 2018-06-29 |
| Returned To Mfg | 2018-06-29 |
| Catalog Number | 100/461/000 |
| Lot Number | 3528968 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS, MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-29 |