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

Catalog Number 307300

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that over the last several months the facility staff were reporting multiple problems with the jelco safety protect iv catheter.The catheter was not exhibiting a flash back of blood, including those that were performed with the assistance of a venous illuminator, where venous access could be validated.The problem has created multiple iv access attempts on a very vulnerable neonatal patient population, and even those infants that are full term with easily accessible access.

Manufacturer Narrative

One jelco safety protect iv catheter was returned for analysis.The introducer was noted to be delivered with the guard fully advanced (locked out), the catheter assembly was loose, the catheter assembly tube was flattened in front of the hub component and no unusual conditions present within the introducer.The catheter tube was noted to have light and dark areas that indicate the presence of material inside the catheter tube.The flattening of the tube may be due to routine handling (the sample being loose in the delivery packaging).Testing of the catheter using a water filled syringe indicated that it is not obstructed as water flowed through it.Testing of fluid flow through the introducer per smiths standard test method confirmed that flashback (fluid flow) did not occur.A wire probe inserted into the cannula lumen stopped at approximately.25 inches travel, indicating a blockage.The resistance to advancement was greater than the bending strength of the wire.Previous experience with used introducers shows that dried blood does not offer the resistance encountered; it is inferred that the blockage is due to something else.Based on the findings above, the complaint is confirmed but the root cause is unknown.Since actual type of blockage could not be determined by investigator, and since there was no other similar complaints reported for this lot, this event is considered to be an isolated event and not the result of a systemic quality related issue.

• Brand Name: JELCO SAFETY PROTECTIV CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7759266
• MDR Text Key: 116374467
• Report Number: 3012307300-2018-03239
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071293
• UDI-Public: 10351688071293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2020
• Device Catalogue Number: 307300
• Device Lot Number: 3491237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1