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

Catalog Number 383078

Device Problem Material Discolored (1170)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 50 bd intima-ii" closed iv catheter systems end caps were found discolored before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the batch's prns color were different with other products , 37 of them with the batch number 0049483/0077 were darker, and 13 of them with the batch number 0049483/0082 were lighter, customer needed a closure letter to confirm the reason why prn's color was different".

Manufacturer Narrative

The following fields were updated due to additional information: d10/d11: concomitant medical products: device available for eval yes.D10/d11: concomitant medical products: returned to manufacturer on: 2021-01-09.H6: investigation summary: a device history review was conducted for lot number 0049483.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.Additionally, the sample submitted by the facility was reviewed by our team of quality engineers.After evaluating the device they found that the variation in color was within the accepted variance established by product specifications.Further, the change in appearance was solely a cosmetic change that does not affect product performance.H3 other text : see h10.

Event Description

It was reported that 50 bd intima-ii¿ closed iv catheter systems end caps were found discolored before use.The following information was provided by the initial reporter, translated from chinese to english: "the batch's prns color were diferent with other products , 37 of them with the batch number 0049483/0077 were darker, and 13 of them with the batch number 0049483/0082 were lighter, customer needed a closure letter to confirm the reason why prn's color was different".

• Brand Name: BD INTIMA-II CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 11175505
• MDR Text Key: 228463171
• Report Number: 3006948883-2021-00103
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/04/2023
• Device Catalogue Number: 383078
• Device Lot Number: 0049483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2021
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 02/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1