MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; IV SAFETY CATHETER

Lot Number 3749048

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemostasis (1895)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

Thirteen jelco safety viavalve catheters were returned for analysis.The returned samples were visually evaluated and tested for seal leakage and for seal actuation per procedure and were found to be acceptable.As a result, the reported event could not be confirmed as a manufacturing-related nonconformance.In-process and at post sterile, product is evaluated for seal leakage and is inspected by certified operators using statistically valid sampling plans at defined intervals.If any non-conformances 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.No correction or corrective actions will be conducted by the manufacturing facility at this time as there was no fault found.

Event Description

Information was received that the jelco safety viavalve catheter malfunctioned.It was reported that after puncturing the product to the patient and removing the needle, the collected blood leaked from it because the hemostasis valve did not work.A hemostasis operation was performed to stop any further bleeding.

Manufacturer Narrative

Corrected data: correction: h6 ( method code).

• Brand Name: JELCO
• Type of Device: IV SAFETY CATHETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 10783005
• MDR Text Key: 214511927
• Report Number: 3012307300-2020-10961
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

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: Health Professional
• Device Expiration Date: 01/18/2021
• Device Lot Number: 3749048
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention