A-DCC DENTAL SYRINGE TIP OR POSSIBLY OTHER MFG.
Received Mar 2, 2007 · Event occurred Feb 1, 2007
Report 3015729-2007-00001 · MDR key 822757
Device
Generic name
Dental Syringe Tip
Manufacturer
A-dec, Inc.Model number
NACatalog number
23.0465.00
Lot number
UNK
Product problems
- Tip breakage
Patient
*
- Other (for use when an appropriate patient code cannot be identified)
- Hospitalization required
Narrative
Additional Manufacturer Narrative
ADD'L CATALOG # 23.0464.00, IF A-DEC.
Description of Event or Problem
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.