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 306001

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/31/2018

Event Type  Injury  

Event Description

Information was received indicating that a smiths medical jelco® protectiv® safety i.V.Catheter was found to be leaking around the hub.The iv was then removed and the catheter tip was noted to be separated from the hub.An x-ray, cat-scan and echocardiogram were performed to locate the catheter.Subsequently, exploratory surgery was necessary to attempt to find the retained catheter.There were no further reported adverse effects.

Manufacturer Narrative

Evaluation summary: a device was not returned for investigation.However, two photographs, one of a detached/severed catheter just above the catheter hub nose, with no photo of the unattached segment, and the other a reference photo of a non-defective catheter sample were returned to the manufacturer.The photograph of the defective sample did not include a magnified close up view of the detachment point.Additionally, a device history record review was completed and no manufacturing issues were found.With no device returned, an in depth evaluation could not be performed and no specific root cause can be identified.Based on the photographs and device history review, the complaint allegation was confirmed with no noted problem source.

• 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: 7828110
• MDR Text Key: 118607459
• Report Number: 3012307300-2018-03499
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071187
• UDI-Public: 10351688071187
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/12/2020
• Device Catalogue Number: 306001
• Device Lot Number: 3423775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR