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

Catalog Number 8353BR

Device Problem Material Rupture (1546)

Patient Problems Hematoma (1884); Rupture (2208)

Event Date 07/17/2023

Event Type  Injury  

Event Description

It was reported that the end ruptures after piercing the skin, causing the blood vessel to dilate, rupture and cause extensive hematoma.Use of the product followed the manufacturer's instructions.No other measures were taken after the problem was identified.There were no product labels for collection and no sample available for investigation.The company has not carried out and is not carrying out any field action related to the product involved.Also, no occurrence of the same type caused or contributed to death or serious damage to health in the last two years.It is not known whether the patient had any other injury than the one already mentioned.

Manufacturer Narrative

D4: udi and g5: 510k is unknown; no information has been provided to date.E.Initial reporter name is confidential and unknown; no information has been provided to date.H3: other; device not returned to manufacturer.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

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 CONVENTIONAL SERIVA CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18743862
• MDR Text Key: 335812142
• Report Number: 3012307300-2024-00906
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: UNKNOWN
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: Not provided
• Initial Date FDA Received: 02/20/2024
• 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