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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. MEDEX¿ MICRO BORE EXTENSION SET; FILTER, INFUSION LINE Back to Search Results
Catalog Number FS116
Device Problem Leak/Splash (1354)
Patient Problem Underdose (2542)
Event Date 11/12/2016
Event Type  malfunction  
Manufacturer Narrative
Potential lot number: 3215639, potential expiration date: 05/28/2019, potential device manufacturer's date: 06/15/2016.The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.(b)(4).
 
Event Description
It was reported that a medex¿ micro bore extension set had leaking at the filter while in use on a patient.The patient did not receive all of the intravenous fluid, which led to an increased risk of infection.The device was in place for up to 72 hours, based on standard tubing change practice.The tubing was replaced with a new set.No patient injury was reported.See mfr: 3012307300-2016-00483, 3012307300-2016-00484, and 3012307300-2016-00486.
 
Manufacturer Narrative
One medex¿ micro bore extension set was returned for evaluation.Visual inspection found that the device was in used condition.Functional testing involved a leak test and showed that the returned device did not show a leak when at the filter or solvent bonding areas.The filter leaked out of the hole when saturated as designed.A review of the inspection activity documents was deemed adequate.The indication for use (ifu) states that the device should be changed every 24 hours.Based on the evidence, the complaint was unable to be confirmed.There was no evidence found to suggest the event was caused from an intrinsic defect in the product.
 
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Brand Name
MEDEX¿ MICRO BORE EXTENSION SET
Type of Device
FILTER, INFUSION LINE
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MANUFACTURING SA DE CV
carretera miguel alemán km21.7
parque industrial
monterrey, apodaca nl CP 66 603
MX   CP 66603
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6155686
MDR Text Key61879447
Report Number3012307300-2016-00485
Device Sequence Number1
Product Code FPB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K860803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFS116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/14/2016
Initial Date FDA Received12/08/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/13/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age5 MO
Patient Weight7
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