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

Model Number	305306
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle sheathed through the iv catheter on insertion.Happen to notice the needle separated from the catheter at the insertion site while in the baby.The child, with limited iv access, needed a new iv site.
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
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three (3) product sample photos were received for evaluation.Visual inspection found the photos taken of the complaint sample did not include magnified closed up views of the catheter bevel tip for evidence of mechanical witness marks or manufacturing damage or of the needle guard assembly for evidence of cannula bevel tip irregularities, excess adhesive, mechanical witness marks or manufacturing damage.Causal factor could not be defined with confidence.No functional testing could be performed as no samples were received.The reported issue could not be confirmed per picture provided for evaluation; no fault found.If the product is returned, the manufacturer will reopen this complaint for further investigation.E4 is unknown, no information provided to date., corrected data: h6 event problem patient code.

• 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; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; seventh street plaza; minneapolis, MN 55442
• MDR Report Key: 14956632
• Report Number: 3012307300-2022-13116
• Device Sequence Number: 5395812
• Product Code: FOZ
• UDI-Device Identifier: 10351688071156
• UDI-Public: 10351688071156
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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
• Device Expiration Date: 07/28/2024
• Device Model Number: 305306
• Device Catalogue Number: 305306
• Device Lot Number: 4184189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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