MAUDE Adverse Event Report: ICU MEDICAL, INC. BAG SPIKE W/CLAVE ADDITIVE PORT

Model Number 20126-01

Device Problem Connection error (1116)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2014

Event Type  malfunction  

Event Description

Complaint received concerning disconnect/chemo leakage during initial infusion with use of set-up involving 20126-01 clave bag spike w/add port and baxter aviva d5w bag; plum set with stand alone spiros.It was reported that when the nurse trys to hang the bag spike 20126-01 slipped out of the container.It was a baxter aviva d5w bag".There were no reported adverse consequences.

Manufacturer Narrative

Additional information and device return/set-up devices were requested.As of the date of this report there has been no response from the facility contacts.Device return status: the involved devices/set-ups were not returned for analysis and verification.Lot record review: a review of the mfg.Lot build database for the reported lot# 31-475-y1 (mfg.Date 07/2013) showed 3200 units were mfg.Tested inspected and released.There were no exception documents generated during the lot builds.Findings: the exact causes of the reported event, product experience/issues are unknown.This report and the associated information have been entered in the mfgers.Database for analysis and trending.A two year review of the complaint database for clave bag spike/general connection/leakage issues did record additional reports.A review of those device return investigations identified mixed findings including usage/errors; no defect found; unknown.There were no findings that identified/verified a contributing mfg/design related non-conformance.A review of the mfg.Lot build database for the reported lot# 31-475-y1 (mfg.Date 07/2013) showed (b)(4) were mfg.Tested inspected and released.There were no exception documents generated during the lot builds.

• Brand Name: BAG SPIKE W/CLAVE ADDITIVE PORT
• Type of Device: BAG SPIKE W/CLAVE ADDITIVE PORT
• 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: 4203889
• MDR Text Key: 5152069
• Report Number: 2025816-2014-00087
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20126-01
• Device Catalogue Number: 20126-01
• Device Lot Number: 31-475-Y1
• Other Device ID Number: PR# 25663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/22/2014
• Event Location: Hospital
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SPIROS CONNECTOR; BAXTER AVIVA D5W BAG; HOSPIRA PLUM SET