MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-08-31 for INFANT/CHILD LUMBAR 22G 1 1/2 NDL 04824, 04826, 04827 manufactured by Abbott Laboratories.
[233598]
Report received of an undocumented number of undocumented incidents of the collection tube leaking. The customer reports that viral cultures are sent to an off-site laboratory. The tubes are put into a transport bag and cooler. When the tubes arrive at the off-site lab it has been reported that the fluid has leaked out of the tube and into the bag. The tubes are intact and the lids are intact, but the fluid is in the bag. There have been reports where some of the patients have needed to be re-stuck for additional specimen collection. There have been no reports of adverse patient events. Add'l pt info was requested, but no further info was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018381-2001-00073 |
| MDR Report Key | 350439 |
| Report Source | 05 |
| Date Received | 2001-08-31 |
| Date of Report | 2001-08-01 |
| Date of Event | 2001-07-16 |
| Date Mfgr Received | 2001-08-01 |
| Date Added to Maude | 2001-09-10 |
| 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 | FRANK POKROP ASSOCIATE DIRECTOR |
| Manufacturer Street | 200 ABBOTT PARK RD DEPT. 389 BLDG. J-45 |
| Manufacturer City | ABBOTT PARK IL 600646132 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646132 |
| Manufacturer Phone | 8479378473 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFANT/CHILD LUMBAR 22G 1 1/2 NDL |
| Generic Name | PROCEDURAL TRAY |
| Product Code | IQE |
| Date Received | 2001-08-31 |
| Model Number | NA |
| Catalog Number | 04824, 04826, 04827 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 339735 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | P.O. DRAWER 1009 LAURINBURG NC 28352 US |
| Baseline Brand Name | ADULT LUMBAR PUNCTURE TRAY 20G 3-1/2' |
| Baseline Generic Name | PROCEDURAL TRAY |
| Baseline Model No | NA |
| Baseline Catalog No | 04824, 04826, 04827 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-08-31 |