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	306601
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received that a smiths medical jelco protectiv safety i.V.Catheter severed in a patient at the hospital.The patient's nurse discontinued the patient's wrist iv and it was noticed then that the catheter was not intact.An ultrasound was able to locate the missing piece.Subsequently, the "patient underwent an invasive procedure to remove the piece from their vein".No additional adverse patient effects were reported.
Additional Manufacturer Narrative
One catheter was returned for evaluation.Upon visual inspection of the device, it was found to be severed at approximately 1/64" above the nose of the catheter hub.There was also evidence of dried solution residue noted on the outside diameter of the catheter hub nose.The reported complaint is confirmed.A cause of issue was not determined.In order to assure that our products meet functional requirements, the dimensions of the catheter components (eyelet, tubing, and hub) are tightly controlled.During the manufacturing process, our catheters are tested to assure that the tubing will not tear, break or otherwise fail.During the manufacture, critical parameters are 100% controlled during the different phases.Once the catheters are assembled from the tube, eyelet and hub, the catheters are inspected in-process 100% in order to demonstrate that the catheter tube is properly secured to the hub.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: JELCO PROTECTIV SAFETY I.V. CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8271465
• Report Number: 3012307300-2019-00361
• Device Sequence Number: 13494657
• Product Code: FOZ
• UDI-Device Identifier: 50351688071178
• UDI-Public: 50351688071178
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/25/2021
• Device Catalogue Number: 306601
• Device Lot Number: 3658570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention