MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PERIPHERAL INTRAVENOUS CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	306601
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that clinicians are experiencing issues threading a smiths medical peripheral intravenous catheter.There was no reported injury to the patient.
Additional Manufacturer Narrative
Three unopened samples were returned and examined.Visual inspection found them to be in good physical condition.Upon functional testing, no discrepencies were noted.Evaluation of these devices did not confirm the reported customer complaint.Four unused samples were returned for evaluation.Visual inspection of the device found it to be in good physical condition.Upon functional testing, it was noted three of the four did experience difficulty in advancement a a result of exessive adhesiv on the cannula.These three of the four returned do confirm the reported customer complaint.The cause of issue was determined to be exessive adhesive on the cannula which is a manufacturing fault.
Additional Manufacturer Narrative
Evaluation results: four unused sister jelco safety protectiv plus catheters were visually examined for any potentially related nonconformance's and found to be acceptable.The samples were further evaluated for potential difficult to thread issues by manually advancing the devices.Three of the devices did exhibit difficulty in advancing, due to excessive adhesive on the cannula.Each of the three unopened sister samples were visually examined for any potentially related nonconformance's and found to be acceptable.The same samples were further evaluated for force to advance (fta) and force to lock (ftl) with no nonconformance's noted.   the above nonconformance's were attributed to a manufacturing problem.

• Brand Name: PERIPHERAL INTRAVENOUS CATHETER
• 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: 8488655
• Report Number: 3012307300-2019-01832
• Device Sequence Number: 2798461
• Product Code: FOZ
• UDI-Device Identifier: 10351688071170
• UDI-Public: 10351688071170
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2020

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: 11/06/2021
• Device Model Number: 306601
• Device Catalogue Number: 306601
• Device Lot Number: 3727756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2019
• Supplement Date Received by Manufacturer: 04/18/2019; 04/18/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/13/2019; 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1