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

Catalog Number	MX1390
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354); Decrease in Pressure (1490); Pressure Problem (3012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that during coronary angioplasty a smiths medical medflator®ii inflation syringe system would not hold pressure during release of the stent.After further attempts, the inflation system would continue to not keep pressure.The product was then replaced with no reported adverse effects.
Additional Manufacturer Narrative
One used medflator®ii system was received for analysis.Upon visual examination, cracking was observed at the bonding area of the syringe to the gauge adaptor plate.The medflator was manually plugged in end of the tubing and pressure was applied manually using the syringe; a leak was noted to the crack found in the bonding area.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.Based on the evidence, the complaint is confirmed.However, the root cause is unknown.

• Brand Name: MEDFLATOR®II INFLATION SYRINGE SYSTEM
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7740926
• Report Number: 3012307300-2018-03057
• Device Sequence Number: 19112026
• 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: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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: 05/31/2019
• Device Catalogue Number: MX1390
• Device Lot Number: 3209821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1