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

Catalog Number 446611

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/02/2018

Event Type  Injury  

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received indicating that while the nurse was attempting to pull out a smiths medical jelco® cathlon® i.V.Catheter, the plastic part broke off in the patient.It was reported that approximately 2mm of the plastic came out.Subsequently, the patient had the severed catheter removed in interventional radiology.There were no further reported adverse patient effects.

Manufacturer Narrative

Device evaluation summary: one jelco cathlon iv catheter assembly was returned for evaluation.Immediate inspection of the sample showed the catheter had been cut off at approximately 5.9mm from the hub nose.Further examination of the cut showed the surface was jagged and highly damaged.During production, to assure that the products meet functional requirements the dimensions of the catheter components (eyelet, tubing and hub) are tightly controlled.Once assembled, these products are 100% inspected to demonstrate the catheter tube is properly secured to the hub.In addition, catheter samples from each lot number are subjected to destructive testing to determine minimum break strength.Based on the investigation, the complaint allegation was confirmed.User interface is noted as the problem source, due to evidence that the damage of the device was consistent with the use of the catheter against the device ifu (instructions for use); either through a needle reinsertion or use of a lancet or scissor near the catheter.

• Brand Name: JELCO® CATHLON® I.V. CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7975531
• MDR Text Key: 124022510
• Report Number: 3012307300-2018-04092
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019315118548
• UDI-Public: 15019315118548
• Combination Product (y/n): N
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 446611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention