MAUDE Adverse Event Report: ICU MEDICAL, INC. ORBIT INFUSION SET

Model Number P3081

Device Problems Component(s), broken (1103); Device Or Device Fragments Location Unknown (2590)

Patient Problems Pain (1994); Therapy/non-surgical treatment, additional (2519)

Event Date 02/22/2014

Event Type  malfunction  

Event Description

Int'l (b)(6) complaint received reporting component (needle) separation with use of p3081 orbit device.It was reported that "client was using orbit micro p3081 inserted into thigh near hip.Client experienced pain when stepping off the truck.Later in day he decided to change site and noted that steel needle had separated from plastic base.Tried to remove without any luck.Went to emergency dept.Where doctor opened skin but could not find needle.Pt saw family md (b)(6) 2014 who made a referral to another plastic surgeon.Client told to apply very warm/hot salt water to area in attempt to draw it to surface where he might be able to pull it out with tweezers.Has pain when walking.Pt has an appointment to see a plastic surgeon on (b)(6) 2014.".

Manufacturer Narrative

Manufacturers lot build review: a review of the mfg.Lot build record database for the reported lot#2419409 (mfg.Date 11/2011) shows (b)(4) units were mfg.Tested inspected and released.There were no exception documents.Manufacturer's lot build record review performed.A review of the historical documentation for p3081 components and sub-assemblies and purchased components was also performed.The orbit cannula needle components were a purchased item.Cannula supplier records document the stainless steel components are compliant with iso 9626 standard.This standard includes specified test criteria relevant to material bend/break testing.Conclusion: at this time the involved device has not been returned for analysis and confirmation.The exact cause(s) of the reported incident remain unknown at this time.

• Brand Name: ORBIT INFUSION SET
• Type of Device: ORBIT INFUSION SET
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 3786339
• MDR Text Key: 4430324
• Report Number: 2025816-2014-00036
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2014

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
• Device Operator: Lay User/Patient
• Device Model Number: P3081
• Device Catalogue Number: 41239-06
• Device Lot Number: 2419409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/22/2014
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1