MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. JELCO SERIVA STRAIGHT IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Model Number 8353

Device Problem Material Rupture (1546)

Patient Problem Hematoma (1884)

Event Date 07/17/2023

Event Type  malfunction  

Manufacturer Narrative

D5: operator of device, e1: reporter name address, phone number and email are unknown.Complaint notification was received from brazil foreign regulatory authority anvisa.Original user and reporter are not known.No information is available.H3 - other: device has not been returned and is not available for investigation.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 the end ruptures after piercing the skin, causing the blood vessel to dilate, rupture and cause extensive hematoma.The distributor of this product is cirúrgica fernandes.It is not provided if there was communication to the distributor about the reported problem.The event was classified as type ii- medium risk.Use of the product followed the manufacturer's instructions.No other measures were taken after the problem was identified.Re was a patient involved and it is not known whether the patient had any other injuries.

Manufacturer Narrative

H6.Investigation codes: updated investigation summary: investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: JELCO SERIVA STRAIGHT IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; bijsterhuizen 22 ¿ 08; wijchen 6604 LD; NL 6604 LD
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18727049
• MDR Text Key: 336640523
• Report Number: 3012542015-2024-00004
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K990236
• 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: 04/02/2024

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: Other
• Device Model Number: 8353
• Device Catalogue Number: 8353BR
• Device Lot Number: 3159321E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 04/02/2024
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1