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Catalog Number 391593
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/01/2021
Event Type  Injury  
Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is (b)(4). This site is an oem manufacturing site. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Investigation summary: the sample was received by bd for evaluation. A quality engineer was able to review the returned sample of (1) venflon i 18ga from lot # 0214120 product # 391593 with the reported issue. The dhr of material number 391593 and lot number 0214120 had no quality notifications recorded on this lot. One sample and two photographs have been received from the customer and were used for investigation of the reported defect. The investigating team also used the retention samples of material code 391593 and lot number 0214120 for investigating the reported defect. The retention samples of 0214120 were retested for following investigation. Simulation of retention samples were simulated(damaged) with various media: by hand, by equipment, by sharp accessories (knife / blade), simulation: ptfe tube is pulled by hand. Result: ptfe tube is elongated in length without any breakage of tube. Simulation: quality test - catheter pull test is performed to on instron to check amount of force required to break ptfe tube. Result: ptfe tube broke at approx. 25n force conforms the specification of product (min. 15n) test reports of retention samples of lot number 0124120 and the dhr test report of catheter pull force done on 8th august 2020 during production of lot number 0124120 simulation (by knife). Simulation: ptfe tube is cut by knife. Result: ptfe tube is divided into two pieces and portion attach to catheter is like customer reported defect description. Simulation (by cut with surgical scissors). Simulation: ptfe tube is cut by scissors. Result: ptfe tube is divided into two pieces and portion attach to catheter is like customer reported defect description. Conclusion: there is no issue found related to ptfe tube in plant with respect to process wise. The defect simulated by blade or knife cutting where it cuts into two pieces suggests that the catheter was accidently cut by the blade or knife led to incident of catheter fracture, the defect is generated during withdraw of catheter and there is chance of use of sharp accessories during practice. The rare end of the broken catheter in the photograph is similar to the catheter that was cut by a sharp accessory. The other end of the catheter mimics the reinsertion end of the catheter. Based on the sample received and the photograph shared by the customer it appears that the catheter could have been cut by a sharp knife or blade as the simulation caused to break the piece of the catheter which has floated inside the vein. This will again require the healthcare worker to pull it out in desperation and which may be attempted by cutting it with knife or sessions. The reported incident appears to have occurred due to wrong practice. Catheter is made from a ptfe (polytetrafluoroethylene tubing) also known as teflon tubing. It has a very tough material and cannot easily snap or break. This is a practice issue and requires a trained staff to use the instrument in a right and safe manner. From the plant side, all the associates in the manufacturing were sensitized about the complaint so that they are alert and aware of the customer facing during use of the product. Complaints received for this device and reported condition will continue to be tracked and trended. Based on the above, no additional investigation and no capa is required at this time.
Event Description
It was reported that the venflon i 18ga 1. 2 mm x 45mm experienced a needle that broke. An embedded portion of the needle was left embedded within the patient and required surgical removal. The following information was provided by the initial reporter: 18g iv cannula shaft distorted in patient vein. Lead to surgical intervention for part removal. In er dept. Nursing staff inserted venflon i 18g iv cannula to patient, after 15 min he finds swelling he removed the cannula. While removing the iv cannula, only half of the cannula came out from vein. He informed to clinician for support. Clinician advised surgery for the patient to remove the part of iv cannula. Toady dr naveen chobdar (vascular sur) performed surgery and removed the part. Patient is now stable. Hospital management want thorough investigation of this incidence.
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Brand NameVENFLON I 18GA 1.2 MM X 45MM
MDR Report Key12555551
MDR Text Key274096430
Report Number2243072-2021-02419
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number391593
Device Lot Number0214120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/30/2021 Patient Sequence Number: 1