MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO CONVENTIONAL SERIVA CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Catalog Number 8353BR

Device Problems Difficult to Insert (1316); Difficult to Advance (2920)

Patient Problems Needle Stick/Puncture (2462); Skin Tears (2516)

Event Type  malfunction  

Manufacturer Narrative

No information has been provided to date.Manufacturing device history record review was not performed because manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.There are no images or evidences available, as such a scar was not raised.The supplier has been notified regarding the complaint.If the product is returned, the reporting manufacturer will reopen this complaint for further investigation.

Event Description

It was reported that there was resistance to puncture the skin and when there is a puncture, immediately the vein breaks due to the force used for the procedure.The part where the bevel and plastic is, if romped, tearing the plastic inside the patient's skin, and when withdrawing causes damage.At the skin level, the bevel tip often bends, making puncture difficult.Due to this and several other problems, the customer noticed an increase in puncture attempts on the same patient.Additional information was requested; however, no further information was received.

• Brand Name: JELCO CONVENTIONAL SERIVA CATHETERS
• 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): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; tambore; minneapolis, MN 55442
• MDR Report Key: 15880408
• MDR Text Key: 307666933
• Report Number: 3012307300-2022-27572
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2022

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 Catalogue Number: 8353BR
• Device Lot Number: 3159321E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1