MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PROTECTIV® SAFETY I.V. CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	306501
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical jelco plus catheter was noted to be difficult to thread.Staff were required to pull the needle out in order to thread catheter into the vein.No patient injury resulted.
Additional Manufacturer Narrative
Twenty eight unused protectiv plus complete assemblies were returned for analysis in an unopened package.Force-to-advance testing per smith's procedures indicated that 5 samples exceeded the test maximum value.Examination of these specimens after fta testing indicated excessive adhesive and was above the well of the housing component.Review of technician machine logbook for one of the affected production dates (02may18) indicates that a machine adjustment was made to cannula adhesive delivery station to correct a high adhesive condition.Based on evidence, the complaint is confirmed and the root cause is from a manufacturing issue.

• Brand Name: PROTECTIV® SAFETY I.V. CATHETERS
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7711117
• Report Number: 3012307300-2018-02833
• Device Sequence Number: 805941
• Product Code: FOZ
• UDI-Device Identifier: 10351688071163
• UDI-Public: 10351688071163
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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: No Information
• Device Expiration Date: 05/02/2021
• Device Catalogue Number: 306501
• Device Lot Number: 3623549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1