MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-23 for CLINIMACS TUBING SET 161-01 manufactured by Miltenyi Biotec Gmbh.
[41019732]
Patient Sequence No: 1, Text Type: N, H10
[41019733]
The customer complained a broken spike of the drip chamber during insertion of the pall filter the event was detected during set up of the clinimacs tubing set ce. No risk to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00058 |
| MDR Report Key | 5520870 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-23 |
| Date of Report | 2016-03-23 |
| Date Mfgr Received | 2016-03-03 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2016-03-23 |
| 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 NANCY JOHANSEN |
| Manufacturer Street | 85 HAMILTON ST |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 6172180062 |
| Manufacturer G1 | MILTENYI BIOTEC GMBH |
| Manufacturer Street | FRIEDRICH-EBERT-STRASSE 68 |
| Manufacturer City | BERGISCH GLADBACH, 51429 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 51429 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINIMACS TUBING SET |
| Generic Name | CLINIMACS TUBING SET |
| Product Code | OVG |
| Date Received | 2016-03-23 |
| Catalog Number | 161-01 |
| Lot Number | B2396 |
| Device Expiration Date | 2018-04-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTENYI BIOTEC GMBH |
| Manufacturer Address | FRIEDRICH-EBERT-STRASSE 68 BERGISCH GLADBACH, 51429 GM 51429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-23 |