MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-04 for 12CC SALINE SYRINGE (10CC) 8881570121 manufactured by Covidien.
[182215148]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[182215149]
The customer reports that the emt stated that he routinely affixes the flush syringe to the extension sets to prepare them for iv starts. He then depresses the plunger rod to prime the system with saline, but has observed that after the extension set has been visually confirmed to be filled with saline the solution spontaneously returns to the syringe while lying undisturbed on countertop.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2020-08953 |
| MDR Report Key | 9786762 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-04 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 12CC SALINE SYRINGE (10CC) |
| Generic Name | SALINE, VASCULAR ACCESS FLUSH |
| Product Code | NGT |
| Date Received | 2020-03-04 |
| Returned To Mfg | 2020-03-03 |
| Model Number | 8881570121 |
| Catalog Number | 8881570121 |
| Lot Number | 19I1074 |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |