MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT

Model Number DADE ACTIN FSL ACTIVATED PTT REAGENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Type of Device: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 7709777
• MDR Text Key: 114675354
• Report Number: 9610806-2018-00076
• Device Sequence Number: 1
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: 00842768003882
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K863594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2019
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445714
• Device Lot Number: 556910A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR