MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-22 for CLINIMACS CD34 REAGENT 171-01 manufactured by Miltenyi Biotec Gmbh.
[24526044]
Conclusion: this complaint is classified as application failure.
Patient Sequence No: 1, Text Type: N, H10
[24526045]
The customer reported that one of their clinimacs cd34 reagents failed in regard that the grey rubber stopper in the vial completely collapsed in on itself when inserting the universal vial adapter (mckesson, cat #ur12b20109) in order to remove the reagent and transfer it to a bag. This resulted in the cd34 reagent being exposed to the environment and not sterile, rendering it unacceptable for use in the cell manufacturing procedure. There was a backup vial of the clinimacs cd34 reagent in place which was used to successfully complete the cell separation procedure. Therefore the patient's treatment was not compromised. Based on the information provided an adverse event for the patient can be excluded. The event happened at: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2015-00006 |
| MDR Report Key | 4959955 |
| Date Received | 2015-07-22 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-06-17 |
| Date Mfgr Received | 2015-06-28 |
| Date Added to Maude | 2015-08-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | 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 | 51429 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 51429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CLINIMACS CD34 REAGENT |
| Generic Name | CLINIMACS CD34 REAGENT |
| Product Code | KSR |
| Date Received | 2015-07-22 |
| Model Number | NA |
| Catalog Number | 171-01 |
| Lot Number | 6150407007 |
| ID Number | 04049934004827 |
| Device Expiration Date | 2015-09-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 1 GLADBACH 51429 GM 51429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-22 |