MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA II CATHETER; INTERVASCULAR CATHETER

Catalog Number 383282

Device Problem Leak/Splash (1354)

Patient Problem Pain (1994)

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: in response to the event reported by the facility a device history review was conducted for lot number 8037289.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.Dhr review(lot#8037289 ): the complaint gauge is 22g,assembly at auto line 1 in feb.2018,packaging at r245 packing machine in aug.2018, lot quantity is 136k.Reviewed the in process test and outgoing test report for this lot product, and all test results met the product specifications with no abnormality.Reviewed the production records and machine troubleshooting records for this lot product, no abnormality, deviation or rework activities found.The positive pressure connector lot number for this product is lot#17096751/17105647/17106258/17045408.Reviewed the incoming inspection result, no abnormality found for it.Two retained samples of this batch were taken, and the positive pressure connector is connected to the standard ruhl connector for flow test.The positive pressure connector can be well activated, and the test results meet the product requirements.Then, the two products were tested for leakage of 45psi, and no leakage was found.No similar compliant is received from the complaint lot.No abnormality found on process, as no defective sample returned, and use condition is unknown.The root cause of positive pressure obstructed and fluid leakage cannot be determined.

Event Description

It was reported that the bd intima ii catheter experienced leakage.The following information was provided by the initial reporter, translated from chinese to english: due to chest tightness, closed indwelling needle was used to reduce the number of patient punctures on (b)(6) 2021.After puncturing, positive pressure obstructed and fluid leakage occurred, causing the patient a second puncture and pain.Replaced the indwelling needle immediately to ensure safe treatment.

• Brand Name: BD INTIMA II CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13048976
• MDR Text Key: 287912623
• Report Number: 3014704491-2021-00369
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/08/2021
• Device Catalogue Number: 383282
• Device Lot Number: 8037289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2018
• 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