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 2017-11-28 for MONOJECT 8881245164 manufactured by Covidien.
[93122230]
Submit date: 11/28/2017. 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
[93122231]
The customer reports that the bone marrow aspirate needle broke off in the patient's iliac crest during a procedure. Forceps were used to pull out the broken piece.
Patient Sequence No: 1, Text Type: D, B5
[109389235]
The report refers to product code 8881245164 illinois sternal-illiac needle with lot number 170300024. A device history record was reviewed and was confirmed that products were produced accomplishing quality requirements no non-conformance reports (ncr)s were found it. No samples were provided for evaluation, the preventive and corrective actions for this complaint will be documented on a formal corrective/preventative action (capa). A qa alert was issued at the manufacturing facility for the incoming inspection area. 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 | 1282497-2017-05486 |
| MDR Report Key | 7064542 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-28 |
| Date of Report | 2018-02-22 |
| Date of Event | 2017-11-09 |
| Date Mfgr Received | 2017-11-09 |
| Date Added to Maude | 2017-11-28 |
| 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 | 2017-11-28 |
| Model Number | 8881245164 |
| Catalog Number | 8881245164 |
| Lot Number | 170300024 |
| 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 | 1. Other | 2017-11-28 |