MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-10-23 for NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR BL+A209Y/V803 manufactured by Nipro (thailand) Corp. Ltd..
| Report Number | 8041145-2019-00009 |
| MDR Report Key | 9226990 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-10-23 |
| Date of Report | 2019-11-19 |
| Date of Event | 2019-09-25 |
| Date Facility Aware | 2019-09-28 |
| Report Date | 2019-10-23 |
| Date Reported to FDA | 2019-10-23 |
| Date Reported to Mfgr | 2019-10-23 |
| Date Mfgr Received | 2019-10-01 |
| Date Added to Maude | 2019-10-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MICHELLE TEJADA |
| Manufacturer Street | 3150 NW 107 AVENUE |
| Manufacturer City | MIAMI FL 33172 |
| Manufacturer Country | US |
| Manufacturer Postal | 33172 |
| Manufacturer Phone | 3055997174 |
| Manufacturer G1 | NIPRO (THAILAND) CORP. LTD. |
| Manufacturer Street | 10/2 MOO 8, BANGNOMKO, SENA |
| Manufacturer City | AYUTHAYA,, 13110 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 13110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR |
| Generic Name | BLOODLINE |
| Product Code | FJK |
| Date Received | 2019-10-23 |
| Returned To Mfg | 2019-10-30 |
| Model Number | BL+A209Y/V803 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIPRO (THAILAND) CORP. LTD. |
| Manufacturer Address | 10/2 MOO 8, BANGNOMKO, SENA AYUTHAYA,, 13110 TH 13110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-23 |