MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-04-01 for J NEEDLE SET 7836 manufactured by Cadence Inc..
[17928192]
On (b)(6) 2011, it was reported that during a procedure the needle bent. No info was available on whether the procedure was completed. If add'l info is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[18243280]
Cadence acknowledges this report does not meet the thirty day reporting requirements. This was unintentional. This report is being filed after it was identified as non-compliant during an internal review of our complaint files. While the actual device was not returned for evaluation, the reported needle bent was confirmed by photographic evidence. The cause of the needle bent could not be determined from the photograph.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1213649-2013-00014 |
| MDR Report Key | 3038037 |
| Report Source | 07 |
| Date Received | 2013-04-01 |
| Date of Report | 2011-07-12 |
| Date of Event | 2011-07-12 |
| Date Mfgr Received | 2011-07-12 |
| Device Manufacturer Date | 2011-03-15 |
| Date Added to Maude | 2013-05-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT TRAHAN |
| Manufacturer Street | 2080 PLAINFIELD PIKE |
| Manufacturer City | CRANSTON RI 02921 |
| Manufacturer Country | US |
| Manufacturer Postal | 02921 |
| Manufacturer Phone | 4019421031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J NEEDLE SET |
| Generic Name | NEEDLE |
| Product Code | DWO |
| Date Received | 2013-04-01 |
| Model Number | 7836 |
| Catalog Number | 7836 |
| Lot Number | 73676-03 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CADENCE INC. |
| Manufacturer Address | 2080 PLAINFIELD PIKE CRANSTON RI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-01 |