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

Catalog Number	MX448HFB
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See mfr: 3012307300-2017-01730 and 3012307300-2017-01797 (same patient).
Event or Problem Description
It was reported that the filter of a medex ultra small bore extension set was leaking.It was noted that the patient's bed was wet around twelve hours after infusion was started.There was no leakage noted from any of the connections.Upon inspection, the lipid filter was clogged with blood.The wet on the bed look more like total parenteral nutrition (tpn).It appears that the filter was leaking somewhere, causing the tpn and blood to back up.None of the pumps alarmed.No injury was reported.
Additional Manufacturer Narrative
Three used and one unused medex¿ ultra¿ small bore extension sets were returned for investigation.The used samples were contaminated with blood residue on the filter and tubing, and thus were not functionally tested.A visual inspection was performed on all samples and no visible defects were found.The unused sample had a stopcock attached to it that was not part of the reported device.Functional testing on the unused sample was performed and no leakage was observed.The complaint was not confirmed, and no root cause was determined.

• 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: 6776942
• Report Number: 3012307300-2017-01727
• Device Sequence Number: 1539562
• Product Code: FPB
• UDI-Device Identifier: 10351688507457
• UDI-Public: 10351688507457
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

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: No Information
• Device Expiration Date: 02/27/2020
• Device Catalogue Number: MX448HFB
• Device Lot Number: 3374802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 09/18/2017
• 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: TOTAL PARENTERAL NUTRITION