MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-29 for MONOJECT 8881245164 manufactured by Covidien.
[93281633]
Submit date: 11/29/2017. An investigation is currently underway. Upon completion, the results will be forwarded. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[93281634]
The customer reports that the bone marrow needle broke during a procedure.
Patient Sequence No: 1, Text Type: D, B5
[109157368]
A device history record (dhr) was reviewed and was confirmed that products were produced accomplishing quality requirements. Two used samples were received for evaluation. The product is provided by an external supplier. The samples were analyzed and a detachment of the device was observed. The reported condition is confirmed. The root cause has been addressed with the supplier. All the investigation, preventive and corrective actions for this complaint will be documented on a formal corrective and preventative action (capa) requested through a suppliers corrective action requirement (scar). A qa alert was issued at the cardinal site for the incoming inspection area to alert them to elevate the inspection process. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2017-05497 |
| MDR Report Key | 7069428 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-29 |
| Date of Report | 2018-02-22 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-11-09 |
| Date Added to Maude | 2017-11-29 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | BOULEVARD INSURGENTES 19030 |
| Manufacturer City | TIJUANA 22225 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22225 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOJECT |
| Generic Name | NEEDLE, ASPIRATION AND INJECTION, REUSABLE |
| Product Code | GDM |
| Date Received | 2017-11-29 |
| Model Number | 8881245164 |
| Catalog Number | 8881245164 |
| Lot Number | 170300024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | BOULEVARD INSURGENTES 19030 TIJUANA 22225 MX 22225 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-29 |