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

Catalog Number FS116

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

Potential lot number: 3215639, potential expiration date: 05/28/201.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.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, 3012307300-2016-00485, 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 water leak test and showed that the returned device leaked at the center of the filter.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 root cause is attributed to the use of the device inconsistent with its ifu.There was no evidence found to suggest the event was caused from an intrinsic defect in the product.

• 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 Key: 6155743
• MDR Text Key: 61870167
• Report Number: 3012307300-2016-00484
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860803
• Number of Events Reported: 1
• 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

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2016
• 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 Number: 1
• Patient Age: 4 MO
• Patient Weight: 7