MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO PROTECTIV SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Model Number	308500
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: d4: lot number, expiration date, and h4: manufacture date are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that a "writer" was used to initiate an iv.An 18g needle was used to attempt the line in the left antecubital (ac).Upon threading iv cannula, resistance felt, flash of blood seen initially, but not during threading.The "writer" attempted to pull iv cannula out as patient complaining of pain and resistance to threading felt, but increased resistance felt by writer when attempting to pull iv cannula out.After initial resistance, writer felt sudden release of tension, and iv cannula was removed from patient's ac.On inspection of iv cannula, cannula was noted to be shorter than normal when compared to intact iv cannula of same gage and end-piece noted to be jagged on the edge.The patient's ac was felt, no bumps or bruising noted, patient remained vitally stable throughout, not complaining of pain post removal of iv catheter.Dressing and pressure applied to patient's left ac maintained for 2 minutes post removal of iv cannula.Patient aware of complications on iv attempt, denied questions when asked by writer.The end piece that broke off was never located.The primary nurse and other user palpated the area and were unable to locate the end-piece.The emergency physician believed that the end piece of the catheter became lodged into the subcutaneous tissue of the patient.The patient made aware of incident, suspect the piece remains in patients subcutaneous tissue but not confirmed.
Additional Manufacturer Narrative
Device evaluation: no product nor photographs have been returned, therefore no failure investigation could be made on the product to evaluate/replicate the reported problem.Based on the evidence currently available, the reported allegation could not be confirmed, therefore no action will be implemented at this time.If the product will become available, the investigation will be reopened.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: JELCO PROTECTIV SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16879502
• Report Number: 3012307300-2023-05221
• Device Sequence Number: 5830249
• Product Code: FOZ
• UDI-Device Identifier: 10351688071309
• UDI-Public: 10351688071309
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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 Model Number: 308500
• Device Catalogue Number: 308500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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