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

Catalog Number	MX448HFB
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2017
Type of Reportable Event	Malfunction
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 a medex¿ ultra¿ small bore extension set was leaking from the seam of the female part of the filter.The leak occurred after the device had been in use for five to seven hours.The filter was removed and replaced.Dex was obtained to check blood sugar.The patient was monitored for signs of sepsis.No injury was reported.See mfr: 3012307300-2017-01017 and 3012307300-2017-01044.
Additional Manufacturer Narrative
One used device was received for evaluation without its original packaging.Visual inspection of the device found a crack on the female port of the blue filter.Functional testing involved a water leak test by introducing water using a syringe, which showed that there was leakage present at the female port of the blue filter.A review of the inspection activities documents was conducted and deemed adequate.A review of the assembly process was confirmed to be adequate.The reported defect was unable to be replicated during testing.Based on the evidence, the root cause was unable to be definitively concluded; it was suspected that the device failure was related to mishandling during connection of the port.It was determined that the device failure was not attributed to a manufacturing issue.

• 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: 6552434
• Report Number: 3012307300-2017-01018
• Device Sequence Number: 18913286
• Product Code: FPB
• UDI-Device Identifier: 10351688507457
• UDI-Public: 10351688507457
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2016

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 Catalogue Number: MX448HFB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2017
• Supplement Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SETSOURCE MICROCLAVES REF # (B)(4)
• Patient Age: 7 DA