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

Catalog Number 383406

Device Problems Out-Of-Box Failure (2311); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2017

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 by the nurse that the bd intima-ii¿ closed iv catheter system had brownish-red foreign matter inside the un-opened packaging.Found before use.No serious injury or medical intervention noted.

Manufacturer Narrative

Results - bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for foreign matter with the incident lot was observed.The foreign matter was seen outside of the liquid flow path.It looks to be lubricating oil.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion - the most probably root cause is the foreign matter was on the production line which resulted in the defect.However, since the foreign matter was found outside the fluid pathway this is not a significant issue.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR 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 ; 8015652845
• MDR Report Key: 7123336
• MDR Text Key: 95477204
• Report Number: 3006948883-2017-00166
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K143610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/23/2020
• Device Catalogue Number: 383406
• Device Lot Number: 7139386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other