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 Therapy/non-surgical treatment, additional (2519); Device Embedded In Tissue or Plaque (3165)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

Int'l ((b)(4)) complaint received reporting component (needle) separation with use of p3081 orbit device.The information (as translated) received reports that ".Patient has a broken needle in the body." follow information has been requested but as of the date of this report, there has been no response.

Manufacturer Narrative

Mfr lot build review: a review of the mfr lot build record database for the reported lot #2455954 (mfr date 02/2012) shows 2000 units were mfr tested, inspected and released.There were no exception documents generated during the lot build.Mfr 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 dr.; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 4567530
• MDR Text Key: 18546056
• Report Number: 2025816-2015-00003
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2014

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: P3081
• Device Lot Number: 2455954
• Other Device ID Number: PR28325 CM35172612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Home
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1