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

Catalog Number 383055

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

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

Event Date 09/14/2021

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.

Event Description

It was reported that the bd intima ii plus¿ iv catheter had foreign, yellow discoloration on the inner top web of its packaging.The following information was provided by the initial reporter, translated from chinese to english: "in fifth ward of gynecology, there was yellow foreign matter on the outside of the product when the package was opened".

Event Description

It was reported that the bd intima ii plus¿ iv catheter had foreign, yellow discoloration on the inner top web of its packaging.The following information was provided by the initial reporter, translated from chinese to english: "in fifth ward of gynecology, there was yellow foreign matter on the outside of the product when the package was opened".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-29.Investigation summary: a device history review was conducted for lot number 0322695.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, an opened packaging unit was submitted to our facility.Our engineers were able to identify the brown foreign matter and submitted the material for composition testing.The foreign material was identified as fumaric acid.This material is not present on the manufacturing floor.Due to these observations and the breached seal of the packaging unit our engineers were not able to associate the root cause for this complaint with the manufacturing process.H3 other text : see h10.

• Brand Name: BD INTIMA II PLUS¿ IV CATHETER
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12658026
• MDR Text Key: 284186285
• Report Number: 3014704491-2021-00202
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/05/2024
• Device Catalogue Number: 383055
• Device Lot Number: 0322695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2020
• 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