MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-05-24 for ADULT LUMBAR PUNCTURE TRAY 20X3 1/2 4301C manufactured by Allegiance Healthcare Corp..
[189336]
Spoke with asst. Nurse mgr on 4/30/01, who stated on the day of the event, a pt had a lumbar puncture performed. The stopcock leaked and they were unable to obtain a pressure reading. They opened another kit and had the same experience. They scheduled a follow up lumbar puncture for the following tuesday. At that time, the child had the third lumbar puncture, and they were able to obtain a pressure reading and noted that the extension tubing was leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2001-00162 |
| MDR Report Key | 334639 |
| Report Source | 05,06 |
| Date Received | 2001-05-24 |
| Date of Report | 2001-05-24 |
| Date of Event | 2001-04-20 |
| Date Mfgr Received | 2001-04-27 |
| Device Manufacturer Date | 2000-11-01 |
| Date Added to Maude | 2001-05-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2001-05-24 |
| Model Number | 4301C |
| Catalog Number | 4301C |
| Lot Number | L0P049 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 323984 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. 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 | 2001-05-24 |