MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MODIFICATION OF JELCO JELCO -W AND JELCO PLUS I.V.; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

Model Number	305706
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter shear occurred while in the patient's vein.Another device was able to be used to complete the procedure.
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.No product sample was received; therefore, visual and functional testing could not be performed.One photo for analysis was received.The photo displayed an empty plastic bag.Unfortunately, the photo provided did not include views of the affected device to evaluate for potential non-conformances.The actual sample was not returned and photos of the affected device were not available, we were unable to perform an in-depth investigation.Causal factor could not be defined with confidence.All materials in the manufacturing process, as well as all finished good products are released to market based on approved quality specification.Product was released after the review of all acceptance of applicable documentation.Premature removal of the introducer needle from the catheter can result in catheter shear upon insertion.The catheter is thin wall by design and needs the needle in order to thread properly into the vessel, with the needle acting as a guide wire during the process.Additionally, in terms of background information, it was important to note that catheter shear can be attributed to practices not supported by the infusion nurses society standards of practice.These types of practices include, but were not limited to, reinsertion of the needle during initial intravenous (iv) placement.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.Complaint information will continue to be monitored.The manufacture regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.

• Brand Name: MODIFICATION OF JELCO JELCO -W AND JELCO PLUS I.V.
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13829795
• Report Number: 3012307300-2022-04801
• Device Sequence Number: 16391595
• Product Code: FOZ
• UDI-Device Identifier: 10351688071149
• UDI-Public: 10351688071149
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: 09/16/2024
• Device Model Number: 305706
• Device Catalogue Number: 305706
• Device Lot Number: 4203226
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown