MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIROS, CLOSED MALE LUER W/RED CAP, 10 UNITS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH2000SC-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded.Without the returned device a probable cause is unable to be determined.
Event or Problem Description
A medsun mandatory medwatch report was received that stated, "patient was receiving vidaza injection with closed-system transfer device attached to the end of the syringe.Nurse met resistance with vidaza and while attempting to push the drug, vidaza sprayed out of the closed-system transfer device spraying onto nurse and patient." additionally, the customer stated the only set up nursing did was attach the needle to spiros and there were no issues during priming/set-up of the syringe in question.The location where leakage was observed was in the middle of the device.The inside tube seemed to rupture and clear fluid filled the outer walls from the inside.There were no observed component damages and anomalies, they could only see the clear fluid (medication).The original procedure was to administer vidaza.The event occurred in an outpatient treatment facility.There was patient involvement and no report of human harm.
Additional Manufacturer Narrative
No product samples were returned for investigation, however, a series of photographs were returned, one showing the product pouch label and one small low resolution embedded photo of a spinning spiros.No leakage was able to be observed from the low resolution photograph.The dhr was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.Without return of the affected sample probable cause cannot be identified based on the information that has been provided.

• Brand Name: SPIROS, CLOSED MALE LUER W/RED CAP, 10 UNITS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 11473394
• Report Number: 9617594-2021-00085
• Device Sequence Number: 14372249
• Product Code: FPA
• UDI-Device Identifier: 00840619042769
• UDI-Public: (01)00840619042769(17)250901(10)5021931
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K070532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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 Expiration Date: 09/01/2025
• Device Catalogue Number: CH2000SC-10
• Device Lot Number: 5021931
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLATIPAK 3 ML LUER-LOK TIP SYINGE, BD MFR; SAFETYGLIDE NEEDLE, 25G X 5/8 INCH, BD MFR; VIDAZA, UNK MFR