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

Catalog Number 3060

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Hematoma (1884)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

Please see mfr # 3012307300-2018-02206 for related device indicent the day prior.

Event Description

It was reported that when administering an iv the iv catheter kinked and caused the patient to have a hematoma.Nurse attempted a second time and it happened again.No patient injury (serious) was associated with the incident.

• Brand Name: JELCO® PROTECTIV® PLUS 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 north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA ASD, INC.; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7575274
• MDR Text Key: 110344741
• Report Number: 3012307300-2018-02203
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 50351688071185
• UDI-Public: 50351688071185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041345
• 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: 06/06/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: 3060
• Device Lot Number: 3548193
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/06/2018
• 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: N
• Patient Sequence Number: 1
• Patient Age: 75 YR