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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon attempting to start a iv, when threading the needle, the metal needle perforated the plastic tubing at the end of the hub.This required the infant to require multiple iv attempts.This equipment failure resulted in two unsuccessful iv attempts, causing skin puncture to the baby unnecessarily.
Additional Manufacturer Narrative
There were seven (7) samples sent in (one (1) used and six (6) unused) and three (3) photos provided for investigation.The unused samples were received with the assemblies fully seated and were manually advanced into a vein pad, clicked and locked out as designed with no evidence of cannula tips protruding beyond the guard nose components.The three (3) photos displayed a 24g protectiv device with evidence of catheter shear.Unfortunately, these photos did not include magnified closed up views of the device for evidence of cannula or catheter bevel tip irregularities, mechanical witness marks or manufacturing damage.All seven (7) samples displayed no evidence of cannula or catheter bevel tip irregularities, bent cannula, damage to locking mechanism or catheter hub, catheter severance and eyelet-to-tube tears.Pressure testing, using a water filled syringe, of the unused samples indicated no evidence of leakage in the catheter tubing.The used sample displayed normal flash in the flashback chamber with evidence of a puncture in the tubing where the tube meets the hub nose.The puncture was consistent with the ?j?-shape profile of the cannula, resulting in catheter shear.Based on device analysis, the complaints were determined to be due to a variation in insertion technique.Dhr review was done, no issues related to the original complaint were found.

• 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): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 14th floor, north tower; minneapolis, MN 55442
• MDR Report Key: 14956573
• Report Number: 3012307300-2022-13114
• Device Sequence Number: 5497581
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2025
• Device Model Number: 305306
• Device Catalogue Number: 305306
• Device Lot Number: 4246946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• 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: 06/13/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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