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

Catalog Number	MX1390
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).This device is same and/or similar to a device approved for distribution in the us.
Event or Problem Description
It was reported that a medex¿ medflator®ii inflation syringe system was leaking during an angioplasty procedure.The product was replaced.No injury was reported.
Additional Manufacturer Narrative
One device was returned for evaluation.Visual inspection of the unit found it to be have craking at the bonding area of the syringe to the guage adaptor plate.No other physical damage noted.Unit was then functionally tested by manually pluggin the end og the tubing and applying pressure using the syringe.While doing so, the unit was found to leak at the cracking area of the bonding as noted in the visual inspection.The customer's complaint was confirmed.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• 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: 7338397
• Report Number: 3012307300-2018-00604
• Device Sequence Number: 13493520
• 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,foreign,health pr
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: 01/31/2019
• Device Catalogue Number: MX1390
• Device Lot Number: 3132771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 10/30/2018
• Patient Sequence Number: 1