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

Catalog Number	335603
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical jelco® acuvance® safety i.V.Catheter was not separating easily at the hub upon threading the plastic catheter into the patient's vein.Reported use of extra force was needed to separate with a concern of this possibly collapsing the vein from the pressure.There were no reported adverse effects.
Additional Manufacturer Narrative
One hundred twenty five unused jelco® acuvance® safety i.V.Catheters were returned for analysis with the same lot number.Exam of the samples were performed by manual advancement; revealing that a higher than expected effort was required to advance the catheter.Visual examination of the blunt/hook subassembly showed adhesive overflow that extended down the round shaft of the hook component.It is noted that adhesive in this area will result in both increased drag as the hook shaft is pushed through the sealing o-ring that is present in the body component and, more significantly, will result in binding between the shaft and the body component internal features during catheter advancement; confirming complaint.Based on the evidence, the root cause source is from manufacturing.

• Brand Name: JELCO® ACUVANCE® SAFETY I.V. CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7699824
• Report Number: 3012307300-2018-02783
• Device Sequence Number: 1452551
• Product Code: FOZ
• UDI-Device Identifier: 10351688071446
• UDI-Public: 10351688071446
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K012128
• 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): 09/10/2018

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: Health Professional
• Device Expiration Date: 02/23/2021
• Device Catalogue Number: 335603
• Device Lot Number: 3584515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1