MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-05-14 for SYRINGE 150 UL SYRINGE 150 UL 05904528001 manufactured by Roche Diagnostics.
[144957366]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[144957367]
The initial reporter complained of an issue with a roche cardiac pipette. The customer alleged the needle separated from the syringe body. The cap on the end of the device also seemed to be "falling apart. " there was no allegation that an adverse event occurred. The customer could not provide the lot number of the device. The device was requested for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01788 |
| MDR Report Key | 8607292 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-14 |
| Date of Report | 2019-10-09 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-05-14 |
| 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 | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | B. BRAUN MELSUNGEN AG |
| Manufacturer Street | CARL-BRAUN-STRASSE 1 |
| Manufacturer City | MELSUNGEN D-3421 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-3421 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYRINGE 150 UL |
| Generic Name | MICRO PIPETTE |
| Product Code | JRC |
| Date Received | 2019-05-14 |
| Model Number | SYRINGE 150 UL |
| Catalog Number | 05904528001 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |