MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-03-28 for YANKAUER SUCTION TUBE W/SCREW TIP AS165 manufactured by Allegiance Healthcare Corp..
[17437615]
In 2002, a patient was switched from a plastic yankeur to a metal yankeur because the patient's confused mental state created a risk that patient would chew off the tip of the plastic yankeur. The patient aspirated the screw off tip of the metal yankeur and an emergency bronchoscopy was performed to remove the tip from the patient's lung. Patient suffered no adverse consequences. Further conversation with the customer revealed that they were not certain of the agitated patient caused the tip to unscrew, if the device failed in some way.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2002-00048 |
| MDR Report Key | 384972 |
| Report Source | 06 |
| Date Received | 2002-03-28 |
| Date of Report | 2002-03-28 |
| Date of Event | 2002-02-15 |
| Date Mfgr Received | 2002-02-26 |
| Date Added to Maude | 2002-04-01 |
| 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 | 1430 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 | YANKAUER SUCTION TUBE W/SCREW TIP |
| Generic Name | INSTRUMENT |
| Product Code | KCB |
| Date Received | 2002-03-28 |
| Model Number | AS165 |
| Catalog Number | AS165 |
| Lot Number | UNK |
| 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 | 374019 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1430 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | YANKAUER SUCTION TUBE W/SCREW TIP |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | AS165 |
| Baseline Catalog No | AS165 |
| Baseline ID | NA |
| Baseline Device Family | INSTRUMENT |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-03-28 |