MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER

Catalog Number 383033

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

Investigation summary: dhr review: the complaint gauge is 24g,assembly at auto line 3 in apr.2020,packaging at cfs packing machine in apr.2020, lot quantity is 136k.Review the in process test and outgoing test report for this lot product, all test results meet the product specifications, no abnormal for it.Review the production record and machine troubleshooting records for this lot product, no abnormality, deviation or rework activities.No actual sample and picture was returned, and the defects of indwelling needles cannot be determined due to unclear description of complaint.Examined the retained sample from the complained batch and there is no abnormality.Conclusion(s): as no defective sample returned, no abnormal found on process, and the usage situation was unknown, the root cause of the finger injury could not be confirmed." investigation conclusion: in response to the event reported by your facility a device history review was conducted for lot number 0063927.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately, a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system was involved with a needle stick injury after use.It has not been mentioned whether medical intervention was applied as a result, or what final affect the incident had on the device operator.The following information was provided by the initial reporter: fingers were injured when the needle was exposed during the transfusion.

• Brand Name: BD INTIMA-II CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12017840
• MDR Text Key: 261604765
• Report Number: 3006948883-2021-00693
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/04/2023
• Device Catalogue Number: 383033
• Device Lot Number: 0063927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other