MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ MEDFLATOR®II INFLATION SYRINGE SYSTEM; SYRINGE, BALLOON INFLATION

Catalog Number	MX1390
Medical Device Problem Codes	Crack (1135); Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that during a cardiac catheterization procedure, this inflation syringe system did not develop pressure.The product was immediately replaced.No adverse patient effects were reported.
Additional Manufacturer Narrative
One medflator®ii inflation syringe was returned for analysis.Upon visual exam the unit appeared to be assembled correctly with the parts that had been returned.Cracking was noted under magnification at the bonding area of the syringe to the adaptor plate.Unit was functionally tested by manually plugging the end of the tubing and manually applying pressure using the syringe.While applying pressure the unit was found to leak at the cracking area of the bonding area as noted in the visual inspection.No product remaining with lot# listed on dhr of the two bonded components for dimensional inspection.Units are 100% leak tested prior to finished assembly and would have passed specifications to complete the manufacturing process.Based on the evidence, the allegation was confirmed.However, the time frame of cracking was unable to be determined.

• Brand Name: MEDEX¿ MEDFLATOR®II INFLATION SYRINGE SYSTEM
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7682381
• Report Number: 3012307300-2018-02733
• Device Sequence Number: 13821781
• Product Code: MAV
• UDI-Device Identifier: 10351688510020
• UDI-Public: 10351688510020
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K940896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: No Information
• Device Expiration Date: 04/17/2019
• Device Catalogue Number: MX1390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1