MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SMALLBORE EXT SET W/MICROCLAVE CLEAR, CLAMP, ROTATING LUER

Model Number	MC3302
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return for testing and investigation and has not been received.
Event or Problem Description
The event involves a customer allegation against a smallbore ext set w/microclave clear, clamp, rotating luer that leaked while the clinician was disconnecting the patient from the iv line.While flushing the line, the patient commented it was leaking.The clinician confirmed the pump was off and noted the cap had pulled off the tubing of the saline lock.It was noted that blood had started flowing out of the saline lock.The clamp on the device was closed and was replaced with a new device primed with saline.There was no adverse event reported.
Additional Manufacturer Narrative
A portion of a single used mc3302 extension set was returned.The shuntless microclave was cut from the set and not returned as part of the investigation sample.The length of the tubing on the returned mc3302 extension set components was measured (g-3g-629) at 5" in length when a full length tube is 5.5" in length.This suggests that 0.5" of the tubing is missing that would have extended outside the shuntless microclave bond pocket, hence no visible evidence of solvent on the end of the tubing.The end of the tubing that was separated was visually analyzed and it appears to have been cut with a sharp instrument.The dhr for lot # 3710736 and relevant commodities were reviewed and there were no non-conformances found that would have contributed to the reported complaint.

• Brand Name: SMALLBORE EXT SET W/MICROCLAVE CLEAR, CLAMP, ROTATING LUER
• Common Device Name: SMALLBORE EXT SET W/MICROCLAVE CLEAR, CLAMP, ROTATING LUER
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• MDR Report Key: 8066623
• Report Number: 9617594-2018-00155
• Device Sequence Number: 16702777
• Product Code: FMG
• UDI-Device Identifier: 00887709037267
• UDI-Public: 887709037267
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 06/01/2023
• Device Model Number: MC3302
• Device Catalogue Number: MC3302
• Device Lot Number: 3710736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1