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 2018-07-23 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Product Gmbh.
[114675354]
The customer contacted a siemens customer care center (ccc) and reported that she sustained a small cut on her hand from a broken reagent vial. There were no reports of damage to the outside shipping box and the customer indicated that she did not find additional broken reagent vials in other reagent boxes of the same shipment. Siemens investigated whether there were additional reports of broken dade actin fsl activated ptt reagent vials with lot 556910a and found no issue. Siemens was unable to rule out the customer's handling, transport, storage or packaging of the reagent box to be the cause of the broken reagent vials. The reagent is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[114675355]
The customer reported that she sustained a small cut on her hand from broken reagent vials when opening a dade actin fsl activated ptt reagent box. The customer washed the injury with water and soap and applied a bandage. No additional medical intervention was required by the customer. The customer indicated that she disposed of the broken reagent vials; upon inspection of other reagent boxes, the customer determined that there were no other broken reagent vials. There are no known reports of medical intervention or adverse health consequences due to the customer's injury to the hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00076 |
| MDR Report Key | 7709777 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-23 |
| Date of Report | 2018-07-23 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-06-28 |
| Date Added to Maude | 2018-07-23 |
| 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 | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2018-07-23 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445714 |
| Lot Number | 556910A |
| Device Expiration Date | 2019-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH |
| Manufacturer Address | EMIL-VON-BEHRING-STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-23 |