MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-10-20 for AMNIOCENTESIS TRAY W/20 GAX3 4545A manufactured by Allegiance Healthcare Corporation.
[169529]
Dr states needle was dull. Spoke with dr who stated, while performing gestational amniocentesis, dr had difficulty getting the needle through the amniotic membrane. Dr noted during the puncture phase of procedure, dr met more resistance than usual. Dr also noted that the membranes appeared to peel away from the uterine wall. Dr made a second attempt with similiar results. Dr then obtained a spinal needle and was able to obtain clear amniotic fluid without difficulty. There was no evidence of blood or leakage as a result of the incident. The pt did not require medical intervention as result of incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2000-00253 |
| MDR Report Key | 301450 |
| Report Source | 05,06 |
| Date Received | 2000-10-20 |
| Date of Report | 2000-10-20 |
| Date Mfgr Received | 2000-09-21 |
| Date Added to Maude | 2000-10-25 |
| 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 SHARP-GREGG |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475783636 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMNIOCENTESIS TRAY W/20 GAX3 |
| Generic Name | PROCEDURE TRAY |
| Product Code | HIO |
| Date Received | 2000-10-20 |
| Model Number | 4545A |
| Catalog Number | 4545A |
| Lot Number | UNK |
| ID Number | UNK |
| 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 | 291754 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORPORATION |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Baseline Brand Name | AMNIOCENTESIS TRAY W/20 GAX3 |
| Baseline Generic Name | PROCEDURE TRAY |
| Baseline Model No | 4545A |
| Baseline Catalog No | 4545A |
| Baseline Device Family | PROCEDURE TRAY |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K761230 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-10-20 |