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

Catalog Number 3060BR

Device Problem Dull, Blunt (2407)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2023

Event Type  malfunction  

Event Description

It was reported that the product was difficult during handling and puncture, causing injury to the skin of patient at the time of puncture for catheter introduction.It did not pierce the skin, it splits ("tears"), increasing the risk of bloodstream infection.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Udi number is unknown, no information has been provided to date.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.

Manufacturer Narrative

Other, other text: h6: health impact, event methods, evaluation, and conclusion codes: updated.No product was returned, therefore functional testing could not be conducted.A review of manufacturing device history records found no abnormalities or discrepancies that match the reported issue.Based on the available information, the investigation could not confirm the reported issue or attribute a root cause.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: JELCO PROTECTIV 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; minneapolis, MN 55442
• MDR Report Key: 16514336
• MDR Text Key: 311001469
• Report Number: 3012307300-2023-02222
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K030571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

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: 08/07/2023
• Device Catalogue Number: 3060BR
• Device Lot Number: 4035320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1