MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SET; FILTER, INFUSION LINE

Catalog Number	MX448HFB
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that the medex¿ ultra¿ small bore extension set filter disconnected from the patient immediately upon use.It was reported that medical intervention was required, but it was unclear what the intervention was.No patient injury was reported.See mfr: 3012307300-2017-00868 and 3012307300-2017-00870.
Additional Manufacturer Narrative
(b)(4) unused devices were returned for evaluation.Visual inspection of the devices showed that the (b)(4) devices were found to be acceptable.Functional testing involved a water leak test on the five devices and were found to be acceptable.(b)(4) devices from a similar lot were inspected and tested and found acceptable.A review of investigation activity documents was conducted and found acceptable.A review of the device history record for the relevant lot was conducted and found acceptable.A review of the assembly process was conducted and was confirmed to be adequate.Based on the evidence, the complaint was unable to be confirmed.The devices received for analysis did not leak or disconnect.There was no evidence to suggest there was an intrinsic defect in the devices.

• Brand Name: MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SET
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6508915
• Report Number: 3012307300-2017-00869
• Device Sequence Number: 13817460
• Product Code: FPB
• UDI-Device Identifier: 10351688507457
• UDI-Public: 10351688507457
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2017

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: 01/16/2017
• Device Catalogue Number: MX448HFB
• Device Lot Number: 3341503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention