MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-02 for SYRINGE 150 UL 05904528001 manufactured by Roche Diagnostics.
[76769917]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76769918]
The customer stated that they found a defective roche cardiac pipette. When withdrawing the needle of the device from a sample tube, the needle came off from the syringe body of the device and remained embedded in the stopper of the sample tube. The needle was protruding from the stopper. No adverse events were alleged to have occurred. A specific root cause could not be determined as the device was not available for investigation. A production failure or failure from any other source could not be excluded.
Patient Sequence No: 1, Text Type: D, B5
[76778208]
Including this complaint, there have been 21 issues of the same nature within the past 2 years for the complained product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01130 |
| MDR Report Key | 6607470 |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-05 |
| Date of Event | 2017-05-09 |
| Date Mfgr Received | 2017-05-09 |
| Date Added to Maude | 2017-06-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2017-06-02 |
| Model Number | NA |
| Catalog Number | 05904528001 |
| Lot Number | 70163137 |
| 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 | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-02 |