MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-03-11 for CODMAN HEPARIN FLUSHING NEEDLE 45-8002 manufactured by Johnson & Johnson Professional, Inc..
[7762586]
Examination revealed there was a minimal amount of solder present in the joint. It was determined this may have been caused by improper flow of the solder during mfg. This may have lead to the tip becoming dislodged from the needle. Inentory of these devices was reviewed. X-ray examination of solder joints and pull testing was conducted on the available stock and all results were found to be satisfactory. The returned units were considered isolated occurences. Additional test programs which will detect incomplete soldering of this type have been added to the process of manufacture as a corrective action.
Patient Sequence No: 1, Text Type: N, H10
[22083641]
Two heparin flushing needles were used during a cardiovascular procedure and the tip end of each needle fell off. One tip was recovered, and 1 tip was not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1997-00049 |
| MDR Report Key | 74946 |
| Report Source | 07 |
| Date Received | 1997-03-11 |
| Date of Report | 1997-03-11 |
| Date Mfgr Received | 1997-02-20 |
| Date Added to Maude | 1997-03-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN HEPARIN FLUSHING NEEDLE |
| Generic Name | REUSABLE ASPIRATION AND INJECTION NEEDLE |
| Product Code | GDM |
| Date Received | 1997-03-11 |
| Model Number | NA |
| Catalog Number | 45-8002 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 74738 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONAL, INC. |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US |
| Baseline Brand Name | CODMAN HEPARIN FLUSHING NEEDLE |
| Baseline Generic Name | REUSABLE ASPIRATION AND INJECTION NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | 45-8002 |
| Baseline ID | NA |
| Baseline Device Family | HEPARIN FLUSHING NEEDLE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-03-11 |