MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-02-27 for 12CC SALINE SYRINGE (10CC) 8881570121 manufactured by Covidien.
[181801676]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[181801677]
The customer reported the device was noticed to have negative pressure which draws the fluid back into the syringe when the user removes pressure from the end of the syringe. This was discovered during set up after a nurse found the issue while flushing an extension tubing and the fluid returned to the syringe leaving the tube air filled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017768-2020-00802 |
| MDR Report Key | 9764528 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-02-27 |
| 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 | 2010 EAST INTERNATIONAL SPEEDW |
| Manufacturer City | DELAND FL 32724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32724 |
| 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 | 2020-02-27 |
| Model Number | 8881570121 |
| Catalog Number | 8881570121 |
| Lot Number | 19B0244 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2010 EAST INTERNATIONAL SPEEDW DELAND FL 32724 US 32724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |