MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC JELCO CATHETER RADIOPAQUE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	405311
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported the rn attempted to insert iv catheter into patient's left foot.While pulling back slightly on the needle to advance catheter, nurse felt needle puncture the side of the catheter while the catheter was inserted in the patient.Nurse pulled catheter & needle out of patient and noticed part of the catheter was missing and stuck inside patient's foot." providers called to bedside unable to remove retained portion of catheter.X-ray imaging showed small broken catheter tip along the medial aspect of left foot adjacent to base of 1st metatarsal.Subsequently, plastic surgery was consulted with incision made for removal on (b)(6) 2019.No further reported adverse patient effects.
Additional Manufacturer Narrative
Additional information was received about a smiths medical jelco® iv catheter that following removal of the catheter from the patient's foot, the incision was closed with sutures and dressing applied.It was required that twice a day dressings changes were ordered and done with bacitracin.One jelco® iv catheter was returned for analysis in used condition.The visual inspection of the returned sample revealed that 3.64 mm of the catheter were detached, and the severed area was irregular like the tube was torn during the use; confirming complaint.The possible cause was found to be from either needle re-insertion or use of a lancet or scissor.Based on the evidence the conclusion of the investigation was identified to be potential improper use of the device.

• Brand Name: JELCO CATHETER RADIOPAQUE
• 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: 9683507
• Report Number: 3012307300-2019-06141
• Device Sequence Number: 3414243
• Product Code: FOZ
• UDI-Device Identifier: 15019315118340
• UDI-Public: 15019315118340
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2022
• Device Model Number: 405311
• Device Catalogue Number: 405311
• Device Lot Number: 3831400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/14/2020
• 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