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

Catalog Number 8363

Device Problems Difficult to Insert (1316); Defective Component (2292)

Patient Problems Infiltration into Tissue (1931); Skin Inflammation/ Irritation (4545)

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

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 that more force than usually needed was applied when puncturing the injection site.The bevel made the skin scoop up and caused filtration of the vein.The procedure had to be repeated, but the other catheter caused the same issues.No further information is known.

Manufacturer Narrative

H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during the manufacturing process of the device.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

Manufacturer Narrative

Other, other text: h6: health effect code: updated h10: no product sample nor photos were received to forward to the supplier for investigation.A manufacturing device history record (dhr) review and lot sample testing record was received from the supplier stating: "no deviation or irregularities noticed in assembly and manufacturing of product.The test results of pre-dispatch inspection including on the data was also evaluated and found well within specification.Control samples of batch no 3319019k were checked visually.We found all the units were in adequate condition and no abnormality in tab or any other parts of iv cannula was found.We have further tested the sample using dummy arm for venipuncture.We found no issue or any other abnormality during application.We have also checked the needle movement in catheter.We found that the needle was withdrawn from catheter smoothly.No needle stuck or resistance was observed in any of the samples." the reported issue could not be confirmed.If the product is returned, a supplemental report will be filed.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147., corrected data: h6: evaluation codes.

• Brand Name: JELCO SERIVA 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: 15565281
• MDR Text Key: 305883750
• Report Number: 3012307300-2022-22588
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8363
• Device Lot Number: 3319019K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Sex: Female