MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO PROTECTIV PLUS SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Catalog Number 3066

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problems Anxiety (2328); Distress (2329)

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

Udi #, expiration date and lot number are unknown, no information has been provided to date.A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported via email that the catheter sheared 0.2mm from the hub.Pivc was inserted 15 hours prior to incident in right hand.Patient very agitated and restless.Rn caring for patient found pivc out of patient but unable to locate soft transparent section of pivc.Bed and bed area searched.Patient's right arm was ultrasounded and xrayed all showing nil cannula.Bed area searched, medical staff alerted, unable to palpate any foreign bodies in right arm.Us and xray performed all no abnormality detected.Additional information was requested; however, no further information was received.

Manufacturer Narrative

Other, other text: b5: additional event information received (updated b5) h6: event problem and evaluation codes: updates not required.

Event Description

Additional info received via email 14-nov-2022: the patient has gone home as far as the staff are aware.The catheter was never located and there was no long term plan for the patient.They performed ultrasound and x-rays and could not locate the catheter in the patient.

Manufacturer Narrative

Device evaluation: one used catheter assembly was returned without the remainder of the catheter tube, needle guard assembly, sheath component and blister packaging.Visual inspection and functional testing were performed.Visual inspection of the returned device did not display evidence of catheter hub damage or actuator-to-tube security issues.When magnified, the sample displayed evidence of catheter severance at approximately 3/32 inches above the hub nose with a smooth cut noted at the point of severance.Per the manufacturer technical report for investigation into causes of catheter tube separation, the severance is consistent with scissors, or a sharp blade, that was used to remove the device and not the result of a manufacturing nonconformance.Based on the device analysis, the root cause of the complaint was determined to be a variation in user technique.Device history record (dhr) review could not be conducted since the lot number is unknown.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: JELCO PROTECTIV PLUS SAFETY IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 140 william street; minneapolis, MN 55442
• MDR Report Key: 15784852
• MDR Text Key: 303554608
• Report Number: 3012307300-2022-27081
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 3066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 11/09/2022; 06/15/2023
• Supplement Dates FDA Received: 11/15/2022; 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention