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

Catalog Number 3055

Device Problems Material Separation (1562); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

No product was returned.Photos of device were attached for evaluation in poor condition; blurry and not clear.However, evidence was displayed that the catheter was severed 1/3 way from distal end.Other damage was noted at the point of severance and the remainder of the tubing was twisted and kinked.Investigation cannot confirm whether a quality related issue has resulted in the customer reported problem and therefore, root cause could not be defined with confidence.

Event Description

Information was received indicating that during an emergency department stay, a smiths medical jelco® protectiv® safety i.V.Catheter was reported to become sheared off in the patient.An ultrasound was performed; noting the foreign body.The physician numbed the area, performed a blunt dissection, obtained the remainder of the cannula and two sutures were placed.There were no further adverse patient effects.

• Brand Name: JELCO® PROTECTIV® SAFETY I.V. CATHETER
• 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
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA,; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 7932184
• MDR Text Key: 122614625
• Report Number: 3012307300-2018-03938
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR