MAUDE Adverse Event Report: ICU MEDICAL IV SET; ADMIN SET

Model Number	CH-12
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot review: reported lot #3366243 (mfg date 11/2016) shows (b)(4) units were manufactured, tested, inspected, and released with no exception documents cited.
Event or Problem Description
Ch-12 inserted into braun and hospira iv bags, spike easily pulled out of both bags, both in the pharmacy compounding process and also during infusion.Facility reports unprotected chemo exposure.
Additional Manufacturer Narrative
Lot review: reported lot #3366243 (mfg date 11/2016) shows 8,000 units were manufactured, tested, inspected, and released with no exception documents cited.Visual: multiple bag spikes were returned.No mating devices accompanied the returned device.Functional: ten samples were measured and all met iso 8536 design expectations for closure piercing devices.Analysis summary: the complaint of ch-12 assemblies being easy to pull out of iv bags could not be confirmed.
Event or Problem Description
Ch-12 inserted into braun and hospira iv bags, spike easily pulled out of both bags, both in the pharmacy compounding process and also during infusion.Facility reports unprotected chemo exposure.

• Brand Name: IV SET
• Common Device Name: ADMIN SET
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• MDR Report Key: 6708701
• Report Number: 2025816-2017-00159
• Device Sequence Number: 1115603
• Product Code: FPA
• UDI-Device Identifier: 00840619023713
• UDI-Public: 840619023713
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: CH-12
• Device Catalogue Number: CH-12
• Device Lot Number: 3366243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1