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

Catalog Number	306601
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that during an obstetric infusion, the midwife pulled out the catheter because it wasn't in the vein.On removal, the catheter was bent, and the needle had pierced it.There was unknown patient involvement.
Additional Manufacturer Narrative
A1, a2, a3, a4, b5, h3 and h6.Codes: updated.One used device without sheath component and packaging was returned for analysis.Visual examination noted no evidence of kinked catheter, catheter high trim, cannula tip deformation or bent cannula.Leak testing was performed and there was leakage of the catheter tubing confirming the complaint.Examination of the catheter tube displayed evidence of a punctures at the bevel tip and mid-length (where leakage occurred) which is consistent with catheter wall penetration by the cannula due to a redirect during insertion and not the result of a manufacturing nonconformance.Based on device analysis, the complaint cannot be confirmed as a manufacturing related nonconformance, but is highly probable to be due to a variation in insertion technique by the end user.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Event or Problem Description
Additional information was received via email informing that the issue occurred during use on the patient.No clinical consequences.The incident is resolved, no treatment in progress.

• Brand Name: JELCO INTRAVASULAR CATHETER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20324486
• Report Number: 1219611-2024-00044
• Device Sequence Number: 7783117
• Product Code: FOZ
• UDI-Device Identifier: 10351688071170
• UDI-Public: (01)10351688071170(17)251117(10)4351101
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: 11/17/2025
• Device Catalogue Number: 306601
• Device Lot Number: 4351101
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 88 KG