MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for ARTERIAL BLOOD SAMPLER 601LRH manufactured by Carefusion.
[101518569]
Blood gas syringes labeled incorrectly from the mant. Some lots were found to be labeled as "luer slip. " correct product desc is "luer lock. " the product was labeled with the correct mant. , item ref and the correct syringes were in the package. Only issue was the description. Carefusion is the mant. Mant. , item ref numbers are 601lrh and 603lrh, lot#s: 0001192190, 0001190638, 0001187603, 0001160557, 0001157948, 0001157941.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075615 |
| MDR Report Key | 7305697 |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-27 |
| Date of Event | 2018-02-26 |
| Date Added to Maude | 2018-03-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARTERIAL BLOOD SAMPLER |
| Generic Name | ABG/BLOOD GAS SYRINGE |
| Product Code | CBT |
| Date Received | 2018-02-28 |
| Catalog Number | 601LRH |
| Lot Number | 0001192190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | US |
| Brand Name | ARTERIAL BLOOD SAMPLER |
| Generic Name | ABG/BLOOD GAS SYRINGE |
| Product Code | CBT |
| Date Received | 2018-02-28 |
| Catalog Number | 603LRH |
| Lot Number | 0001190638 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | US |
| Brand Name | ARTERIAL BLOOD SAMPLER |
| Generic Name | ABG/BLOOD GAS SYRINGE |
| Product Code | CBT |
| Date Received | 2018-02-28 |
| Lot Number | 0001187603 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | US |
| Brand Name | ARTERIAL BLOOD SAMPLER |
| Generic Name | ABG/BLOOD GAS SYRINGE |
| Product Code | CBT |
| Date Received | 2018-02-28 |
| Lot Number | 0001160557 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | US |
| Brand Name | ARTERIAL BLOOD SAMPLER |
| Generic Name | ABG/BLOOD GAS SYRINGE |
| Product Code | CBT |
| Date Received | 2018-02-28 |
| Lot Number | 0001157948 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-28 |