MAUDE Adverse Event Report: ST PAUL JELCO; CATHETER

Model Number 24 GAUGE

Device Problems Peeled/Delaminated (1454); Separation Failure (2547)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/13/2021

Event Type  malfunction  

Event Description

Information received a smiths medical peripheral intravenous catheters (pivc)|jelco safety viavalve catheters may have broke off.It was reported during the use of the product, the patient removed it by himself.No patient injury.The patient removed the catheter, which had been indwelled in him, by himself.The entire catheter was missing.So the customer took a ct of the patient's body, but the catheter was not found.The catheter was reported to be placed on (b)(6) 2021 and the accidental removal occurred on (b)(6) 2021.Accidental removal event occurred on (b)(6) 2021.No further adverse events reported.

Manufacturer Narrative

Other text: one used 24g viavalve catheter assembly, without sheath, needle guard assembly and blister packaging, and three photos (see attachments) were returned for analysis.The photos displayed a 24g terumo viavalve catheter assembly with no catheter tube present.Initial visual examination of the actual sample confirmed that there was no catheter tube present.Of note, the customer reported that during use of the product, the patient removed the catheter by himself.Additionally, given no abnormalities such as fluid leakage were observed during use by the patient and the catheter tube was not located during the ct scan of the patient? s body, the customer suspected that the patient pulled the catheter with the film dressing.Review of sample with engineering smes did not indicate any definitive root cause for the issue.Review of recent historical data for catheter security on sr-fvp2416p product were confirmed to not only meet specification, but also yield results at a minimum of 97 percent higher than the specification limit per pd3200 (0.67lbs).Of note, the missing catheter tube was observed upon removal of the catheter from the patient.Without the catheter tube from the returned sample available for analysis, the complaint cannot be confirmed as the result of a manufacturing nonconformance.See attached images.In process, in order to assure that our products meet functional requirements, the dimensions of the catheter components (eyelet, tubing, and hub) are tightly controlled.During manufacture, our catheters are tested to assure that the tubing will not tear, break or otherwise fail.During manufacture, critical parameters are 100 percent controlled during the different phases.Once assembled from the tube, eyelet and hub, the catheters are inspected in-process 100% in order to demonstrate that the catheter tube is properly secured to the hub.In-process and at post sterile, product is evaluated for catheter security and visually inspected by operators using statistically valid sampling plans at defined intervals.If any nonconformances are found in process, the product is isolated, non-conformed and immediate action is taken to perform corrections.Sampling plans are based on random sampling selection and are designed to provide a high level of assurance that the true fraction defective is less than or equal to the established aql level for each quality characteristic.As a correction, this complaint is being communicated to appropriate personnel.No further correction or corrective actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.Smiths medical regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.

Event Description

Device evaluation completed and summary in h 10.

• Brand Name: JELCO
• Type of Device: CATHETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; aichi pref.; minneapolis, MN 55442
• MDR Report Key: 11696729
• MDR Text Key: 246424925
• Report Number: 3012307300-2021-03322
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 24 GAUGE
• Device Catalogue Number: SR-FVP2416P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1