MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-12-28 for LINE DRAW ARTERIAL BLOOD GAS KIT (ABG) 4043-2 manufactured by Smiths Medical Asd, Inc..
[407424]
User alleges they have been having problems with syringe plungers sticking when dispensing the sample when using i-stat for arterial blood draws. No blood exposure reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217052-2005-00110 |
| MDR Report Key | 658490 |
| Report Source | 07 |
| Date Received | 2005-12-28 |
| Date of Report | 2005-11-28 |
| Date of Event | 2005-11-01 |
| Date Mfgr Received | 2005-11-28 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2006-01-04 |
| 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 | 0 |
| Manufacturer Contact | TIMOTHY MATSON |
| Manufacturer Street | * |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal | 03431 |
| Manufacturer Phone | 6033523812 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC |
| Manufacturer Street | * |
| Manufacturer City | KEENE NJ 03431 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03431 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINE DRAW ARTERIAL BLOOD GAS KIT (ABG) |
| Generic Name | TRAY, BLOOD COLLECTION |
| Product Code | GJE |
| Date Received | 2005-12-28 |
| Returned To Mfg | 2005-12-14 |
| Model Number | NA |
| Catalog Number | 4043-2 |
| Lot Number | K716081 |
| ID Number | NA |
| Device Expiration Date | 2008-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 647957 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 10 BOWMAN DRIVE KEENE NH 03431 US |
| Baseline Brand Name | LINE DRAW ARTERIAL BLOOD GAS (ABG) KIT |
| Baseline Generic Name | TRAY, BLOOD COLLECTION |
| Baseline Model No | NA |
| Baseline Catalog No | 4043-2 |
| Baseline ID | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K911638 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-28 |