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 2018-01-12 for MONOJECT 8881245164 manufactured by Covidien.
[97106467]
Submit date: 01/12/2018. 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
[97106469]
The customer reports that the needle broke. The customer further reports that no medical or surgical intervention was needed as a result and there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[113800036]
An investigation of the reported condition was performed. Since the lot number was not provided by the customer therefore a review of device history record (dhr) could not been performed. No samples were provided for evaluation. Therefore, the reported condition could not be confirmed. However, based on recently received complaints for the same part number and similar reported issue, the possible root cause may be related to the supplier? S manufacturing process. All the corrective actions and preventative actions (capa) will be documented through a suppliers corrective action report (scar) and capa report. 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 | 9610849-2018-00002 |
| MDR Report Key | 7186354 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-12 |
| Date of Report | 2018-03-07 |
| Date Mfgr Received | 2017-12-20 |
| Date Added to Maude | 2018-01-12 |
| 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 ALMEIDQA |
| 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 | 2018-01-12 |
| Model Number | 8881245164 |
| Catalog Number | 8881245164 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-01-12 |