MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-03-02 for A-DCC DENTAL SYRINGE TIP OR POSSIBLY OTHER MFG. 23.0465.00 manufactured by A-dec, Inc..
[20932083]
A dental syringe tip was ejected out of a syringe and ingested by pt. Pt was sent to hosp for confirmatory radiology. Pt subsequently returned to hosp for f/u radiology to determine if syringe tip had passed. F/u radiology confirmed pt had passed syringe tip. Syringe tip was not recovered for analysis, however, non-a-dcc syringe tips may not be properly retained in the dental syringe due to differences in mfg tolerances. Also, worn o-rings may contribute to syringe tip ejection and this information is available in the instructions for use (ifu). Without the subject syringe tip it is impossible to determine the failure mechanism.
Patient Sequence No: 1, Text Type: D, B5
[21190093]
Add'l catalog # 23. 0464. 00, if a-dec.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3015729-2007-00001 |
| MDR Report Key | 822757 |
| Report Source | 05 |
| Date Received | 2007-03-02 |
| Date of Report | 2007-02-13 |
| Date of Event | 2007-02-01 |
| Date Added to Maude | 2007-03-06 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS LOUISELL |
| Manufacturer Street | 2601 CRESTVIEW DR. |
| Manufacturer City | NEWBERG OR 97132 |
| Manufacturer Country | US |
| Manufacturer Postal | 97132 |
| Manufacturer Phone | 5035389471 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A-DCC DENTAL SYRINGE TIP OR POSSIBLY OTHER MFG. |
| Generic Name | DENTAL SYRINGE TIP |
| Product Code | ECB |
| Date Received | 2007-03-02 |
| Model Number | NA |
| Catalog Number | 23.0465.00 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 810163 |
| Manufacturer | A-DEC, INC. |
| Manufacturer Address | * NEWBERG OR * US |
| Baseline Brand Name | A-DCC DENTAL SYRINGE TIP OR POSSIBLY OTHER MFG. |
| Baseline Generic Name | DENTAL SYRINGE TIP |
| Baseline Model No | NA |
| Baseline Catalog No | 23.0465.00 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-02 |