MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2019-05-02 for CONTAINER 18 GAL CHEMO W SLIDE 8939 manufactured by Covidien.
[143989184]
Additional information has been requested from the distributor but at this time no further details have been provided. 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.
Patient Sequence No: 1, Text Type: N, H10
[143989185]
The customer reports the lid of the sharps container was not sealed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1424643-2019-00536 |
| MDR Report Key | 8575546 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-04-29 |
| Date Mfgr Received | 2019-04-29 |
| Date Added to Maude | 2019-05-02 |
| 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 | 815 TEK DRIVE |
| Manufacturer City | CRYSTAL LAKE IL 600399002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600399002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTAINER 18 GAL CHEMO W SLIDE |
| Generic Name | CONTAINER, SHARPS |
| Product Code | MMK |
| Date Received | 2019-05-02 |
| Model Number | 8939 |
| Catalog Number | 8939 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 815 TEK DRIVE CRYSTAL LAKE IL 600399002 US 600399002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-02 |