MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER

Catalog Number 383019

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

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0168642. Medical device expiration date: 2023-07-26. Device manufacture date: 2020-06-16. Medical device lot #: 0063910. Medical device expiration date: 2023-07-26. Device manufacture date: 2020-06-16. Medical device lot #: 0907739. Medical device expiration date: 2023-07-26. Device manufacture date: 2020-06-16. 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 90 bd intima ii¿ iv catheter prn adapters from lot 0168642, 13 from lot 0063910, and 11 from lot 0907739 had visible silicone particles in their needles. The following information was provided by the initial reporter, translated from (b)(6) to english: "there was visible sillicon particle in the needle, and several batches were influenced, this incident was happened in the psychiatry department".

• Brand Name: BD INTIMA II IV CATHETER PRN ADAPTER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11168049
• MDR Text Key: 247501451
• Report Number: 3006948883-2021-00073
• 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: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383019
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial