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

Catalog Number	326510
Medical Device Problem Codes	Disconnection (1171); Connection Problem (2900)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that when the operator tried to remove the needle and catheter, it remained in the patient.The product was eventually removed.The patient experienced minor injury as a result.
Additional Manufacturer Narrative
One viavalve catheter was returned for evaluation.Upon visual inspection, it was noted that the cannula was not in its normal location within the introducer, and was lodged in the catheter assembly.Additionally, adhesive was found on the housing outside of the well.Adhesive in the well will result in inadequate cannula retention.Incorrect placement of the adhesive dispensing tip relative to the housing/cannula components will cause incorrect adhesive placement as seen.The detached cannula did not show any evidence of adhesive presence.The customer's complaint is confirmed.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: JELCO SAFETY VIAVALVE 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: 7887208
• Report Number: 3012307300-2018-03726
• Device Sequence Number: 186706
• Product Code: FOZ
• UDI-Device Identifier: 15019517078411
• UDI-Public: 15019517078411
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 04/02/2020
• Device Catalogue Number: 326510
• Device Lot Number: 3576233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention