MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. JELCO VIAVALVE SAFETY IV CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 326710

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/1901

Event Type  Injury  

Event Description

Information was received indicating that upon placement of a smiths medical jelco® viavalve® safety iv catheter, the iv catheter broke at the hub.The catheter was removed intact from the patient.There were no further reported adverse effects.

Manufacturer Narrative

Other text: no investigation or root cause analysis could be conducted given that no complaint sample was returned.Given that no product has been provided and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem.Root cause could not be defined with confidence.All materials in the manufacturing process, as well as all finished good products are released to market based on approved quality specification.Product is released after the review of all acceptance of applicable documentation.It is important to note that catheter severance can be attributed to practices not supported by the infusion nurses society standards of practice.These types of practices include, but are not limited to: reinsertion of the needle during initial iv placement.Placement of the iv in a joint of flexion where the catheter will be subject to repeated bending/kinking use of scissors to cut tape when removing an iv catheter may result in inadvertent cutting of the catheter.In order to assure that our products meet functional requirements, the dimensions of the catheter components (eyelet, tubing, and hub) are tightly controlled.During the manufacturing process, our catheters are tested to assure that the tubing will not tear, break or otherwise fail.During the manufacture, critical parameters are 100% controlled during the different phases.Once the catheters are 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, product is accepted based on meeting specification requirements.If any nonconformances are found in process, the product is isolated, non-conformed and immediate corrective action is taken.Inspections and tests are conducted by trained operators using statistically valid sampling plans at defined intervals.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 reported, the reported event could not be verified and/or confirmed with confidence, therefore, no further correction, corrective or preventive 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 not returned to for investigation.Summary from engineer on no product return in h -10.

• Brand Name: JELCO VIAVALVE SAFETY IV CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis,, mn
• MDR Report Key: 9960351
• MDR Text Key: 187691008
• Report Number: 3012307300-2020-03160
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019517078435
• UDI-Public: 15019517078435
• Combination Product (y/n): N
• PMA/PMN Number: K160235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/09/2022
• Device Model Number: 326710
• Device Catalogue Number: 326710
• Device Lot Number: 3883953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention