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

Catalog Number MX448HFB

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/28/2016

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that a medex¿ ultra¿ small bore extension set had a leaking filter while in use on a patient.The patient's blood was backed up to the filter.The nurse was unable to identify any loose connection.It was noted that there was a small amount of blood lost due to the event.No permanent injury was reported.The event was considered resolved.

Manufacturer Narrative

One used ultra¿ small bore extension set was returned for investigation.Visual inspection found that a crack was located on the female luer lock.Functional testing was performed using a manual syringe and it was found that the reported leak was occurring at the female port; the leak was a result of severe cracking.The observed cracking was found to be consistent with overtightening of the device during use or exposure to certain chemicals; however, investigation was unable to definitely determine the root cause of the observed cracking.

• Brand Name: MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SETS
• 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: 6198252
• MDR Text Key: 63084296
• Report Number: 3012307300-2016-00616
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/28/2019
• Device Catalogue Number: MX448HFB
• Device Lot Number: 3236409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• 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