MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH CALCIUM CHLORIDE SOLUTION

Model Number	CALCIUM CHLORIDE SOLUTION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center (ccc).One (1) bottle of calcium chloride (cacl) was found to be cracked in the kit that contains 10 bottles of cacl.There was no damage to the outer box and the remaining reagent in the box has already been used.There are no reports of damage to other reagent bottles.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer cut her thumb when opening a cracked vial of calcium chloride (cacl) reagent.The customer was wearing gloves at the time of the event.The customer received four stitches to treat the cut.There are no known reports of adverse health consequences due to this event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2022-00042 on 21-jul-2022.Additional information (04-aug-2022): siemens reviewed complaint history and trending reports for calcium chloride reagent and there was no indication of an adverse trend in complaints for this product.Evaluation of america's distribution center broken vial trending reports is conducted on a quarterly basis.The customer facility's handling, transport, storage or packaging of the reagent cannot be ruled out as potential causes of the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.

• Brand Name: CALCIUM CHLORIDE SOLUTION
• Common Device Name: CALCIUM CHLORIDE SOLUTION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 15076084
• Report Number: 9610806-2022-00042
• Device Sequence Number: 20168170
• Product Code: JPA
• UDI-Device Identifier: 00842768014222
• UDI-Public: 00842768014222
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K924509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CALCIUM CHLORIDE SOLUTION
• Device Catalogue Number: 10446232
• Device Lot Number: 563910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female