MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD INTIMA-II CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER

Catalog Number 383083

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

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.(b)(4).

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system experienced foreign matter in the fluid path.The following information was provided by the initial reporter: on (b)(6) 2021, when nurse took out the sample for injection, she found contaminants in the sample catheter seat, which did not come into contact with other drugs and instruments, and did not cause harm to the patient or others.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/8/2021.H.6.Investigation: a device history review was conducted for lot number 9323924.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.The sample provided by your facility was submitted for compositional testing.Unfortunately the quantity of the material present on the sample was too small to conclusively identify the foreign material.Based upon the appearance of the foreign material our engineers believe that it may be residue from maintenance on the packaging line.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system experienced foreign matter in the fluid path.The following information was provided by the initial reporter: on (b)(6) 2021, when nurse took out the sample for injection, she found contaminants in the sample catheter seat, which did not come into contact with other drugs and instruments, and did not cause harm to the patient or others.

• Brand Name: BD INTIMA-II CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• MDR Report Key: 11388613
• MDR Text Key: 246816356
• Report Number: 3006948883-2021-00268
• 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: 04/14/2021

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: 12/20/2022
• Device Catalogue Number: 383083
• Device Lot Number: 9323924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1