MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-03 for ORAL SYRINGE 1062683 manufactured by Philips Medical Systems.
[39675320]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[39675321]
The customer stated there was a small piece of plastic in the syringe. Customer stated they received this in 2015. There was no reported patient impact
Patient Sequence No: 1, Text Type: D, B5
[46180242]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2016-01364 |
| MDR Report Key | 5477577 |
| Date Received | 2016-03-03 |
| Date of Report | 2016-02-09 |
| Date Mfgr Received | 2016-02-09 |
| Date Added to Maude | 2016-03-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BETTY HARRIS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORAL SYRINGE |
| Generic Name | ORAL ENTERNAL SYRINGE |
| Product Code | EIB |
| Date Received | 2016-03-03 |
| Returned To Mfg | 2016-02-16 |
| Model Number | 1062683 |
| Lot Number | 2014-41 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-03 |