MAUDE Adverse Event Report: ICU MEDICAL CHEMOLOCK; ADMIN SET

Model Number	CL3520
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.The initial reporter stated that the chemo drug is herceptin.The clinician noticed the leak when it was just forming a drop and was therefore able to gown and glove before manipulating the tubing.Clean up of the small contained spill occurred.There was no exposure to the clinician or patient.No contact with skin.A two year review of complaints database revealed did reveal additional reports for cl3520/similar problem.A review of those investigations where devices were returned recorded mixed results, including no defect, usage issues, cannot determine and mfg/design.
Event or Problem Description
Leak noted below the upper chemolock of cl3520.No adverse patient consequences were reported.
Additional Manufacturer Narrative
The initial reporter stated that the chemo drug is herceptin.The clinician noticed the leak when it was just forming a drop and was therefore able to gown and glove before manipulating the tubing.Clean up of the small contained spill occurred.There was no exposure to the clinician or patient.No contact with skin.A two year review of complaints database revealed did reveal additional reports for cl3520 similar problem.A review of those investigations where devices were returned recorded mixed results, including no defect, usage issues, cannot determine and mfg/design.Visual summary: the reported used device was returned (cl3520) with mating device.Leakage was observed at connection between blue chemo lock body and clear collar at distal end of the tubing.Functional summary: cl3520 was pressure leak tested.A leak was detected.Analysis summary: the cl3520 was confirmed to be leaking due to distorted/damaged o-ring.
Event or Problem Description
Leak noted below the upper chemolock of cl3520.No adverse patient consequences were reported.

• Brand Name: CHEMOLOCK
• Common Device Name: ADMIN SET
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• MDR Report Key: 6762002
• Report Number: 2025816-2017-00165
• Device Sequence Number: 1540481
• Product Code: ONB
• UDI-Device Identifier: 00887709057036
• UDI-Public: 887709057036
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2017

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 Model Number: CL3520
• Device Catalogue Number: CL3520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1