MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-02-02 for manufactured by .
[7920483]
Jms singapore pte ltd is the oem mfr for gambro renal products to produce plume safety avf needle set. Our evaluation of dhr and preserved samples showed that no abnormality was associated with these complained lots. We assure that our products' form, fit and function met the required specification as no defective was detected via all the testing and evaluations. Furthermore, according to info provided by jmsna, this incident was not related to our avf needle, and end-user had commented that it should be an operational error during the treatment. Hence, we conclude that this complaint is not related to our mfg process and no corrective action will be applicable. Lastly, jmss will continue to maintain the good quality of our products and ensure that only good quality products will be delivered to customers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807350-2007-00001 |
| MDR Report Key | 820157 |
| Report Source | 06 |
| Date Received | 2007-02-02 |
| Date Mfgr Received | 2007-01-18 |
| Date Added to Maude | 2007-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | C KOH |
| Manufacturer Street | 440 ANG MO KIO INDUSTRIAL PARK 1 |
| Manufacturer City | SINGAPORE 569620 |
| Manufacturer Country | SN |
| Manufacturer Postal | 569620 |
| Manufacturer Phone | 4571176280 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | FIR |
| Date Received | 2007-02-02 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 807624 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-02 |