MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD CLOSED IV CATHETER NEXIVA¿; INTRAVASCULAR CATHETER

Catalog Number 383078

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd closed iv catheter nexiva¿ contained foreign matter on the device catheter.The following information was provided by the initial reporter: "floccules foreign matter were found on the tip of catheter tube when the package was opened in pediatric surgery.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-02-10.H6: investigation summary a device history review was conducted for lot number 1293550.Our records show that this is the only instance of foreign matter 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.Additionally, a sample was returned to our facility.Our engineers noted that the device was returned in an open packaging unit and that the device was contaminated with a thread-like foreign body.Microscopic inspection of the material was able to identify characteristics consistent with clothing fiber.The issue has been confirmed.Unfortunately due to the fact that that packaging was open, our engineers are not able to rule out on-site contamination, which has prevented them from confirming an association with the manufacturing process.H3 other text : see h10.

Event Description

It was reported that bd closed iv catheter nexiva¿ contained foreign matter on the device catheter.The following information was provided by the initial reporter "floccules foreign matter were found on the tip of catheter tube when the package was opened in pediatric surgery".

• Brand Name: BD CLOSED IV CATHETER NEXIVA¿
• Type of Device: INTRAVASCULAR 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: 13502048
• MDR Text Key: 286664154
• Report Number: 3014704491-2022-00063
• 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,Followup
• Report Date: 02/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383078
• Device Lot Number: 1293550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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