MAUDE Adverse Event Report: ICU MEDICAL, INC VENTED BAG SPIKE, CLAVE; VENTED SPIKE BAG

Model Number 886-CH-14

Device Problems Leak/Splash (1354); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

Lot review: a review of lot 3327039 shows (b)(4) units were manufactured, tested, inspected and released september 2016 with no exception documents cited.

Event Description

Complaint received regarding one 886-ch-14, vented bag spike, lot# 3327039 (mfd.09/17).Report states: the spike ch14 broke to two pieces after it was inserted into the chemo drug bag.There were no adverse patient consequences reported.

Manufacturer Narrative

Lot review: a review of lot 3327039 shows (b)(4) units were manufactured, tested, inspected and released september 2016 with no exception documents cited.Visual inspection: received one used device, clave was not attached to the bag spike.When examined there was inadequate solvent coverage at the bond site.Final analysis: the complaint of a separated bag spike was confirmed.The root cause was an inadequate bond due to no solvent being applied at the bond joint.Manufacturing site was notified.Icu medical will monitor and trend.

Event Description

Report states: the spike ch14 broke to two pieces after it was inserted into the chemo drug bag.There were no adverse patient consequences reported.

• Brand Name: VENTED BAG SPIKE, CLAVE
• Type of Device: VENTED SPIKE BAG
• Manufacturer (Section D): ICU MEDICAL, INC; 4455 atherton drive; salt lake city UT 84117
• Manufacturer (Section G): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• Manufacturer Contact: holly imes ; 4455 atherton drive; salt lake city, UT 84115 ; 8012641747
• MDR Report Key: 6541754
• MDR Text Key: 74414603
• Report Number: 2025816-2017-00104
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K081361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: 886-CH-14
• Device Catalogue Number: 886-CH-14
• Device Lot Number: 3327039
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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