MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-05-07 for ADULT LUMBAR PUNCTURE TRAY 20X3 1/2 4301C manufactured by Cardinal Health.
[19146796]
While pt on table doing procedure, the spinal needle/hub (defective), material sprayed all over the hub. Dr was highly upset. Pt now has to come back to do procedure again. No sample available due to high radiation levels, it was put in disposable unit. Additionally, contact stated they were doing a lp using radioactive dye and when the physician pushed on the syringe, the dye sprayed all over. They decided to proceed with the x-rays, and the dye did not enter the pt's system as desired. The decision to abort the procedure was made at that time and the pt has been rescheduled. The medical team performing the procedure did not require any add'l medical intervention as a result of the incident. Based on the fact that the pt will require a second procedure this complaint will be filed with the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2004-00044 |
| MDR Report Key | 558358 |
| Report Source | 05 |
| Date Received | 2004-05-07 |
| Date of Report | 2004-05-07 |
| Date Mfgr Received | 2004-04-07 |
| Date Added to Maude | 2004-12-09 |
| 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 | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | * |
| Manufacturer Street | 400 EAST FOSTER ROAD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT LUMBAR PUNCTURE TRAY 20X3 1/2 |
| Generic Name | PROCEDURE TRAY |
| Product Code | IQE |
| Date Received | 2004-05-07 |
| Model Number | 4301C |
| Catalog Number | 4301C |
| Lot Number | L4A123 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 548036 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKAGAN ROAD MCGAW PARK IL 60085 US |
| Baseline Brand Name | LUMBAR PUNCTURE TRAY |
| Baseline Generic Name | LUMBAR PUNCTURE |
| Baseline Model No | 4301C |
| Baseline Catalog No | 4301C |
| Baseline ID | NA |
| Baseline Device Family | PROCEDURE TRAY |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-05-07 |