MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 383407

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Inflammation (1932)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.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 nurse found 10 cases of phlebitis after using a bd intima ii¿ iv catheter (22g and 24g).The patient had a fever initially but after removal of the iv, fever was resolved and no additional treatment was needed.

Manufacturer Narrative

Results: the customer returned two samples, the samples were of both a 24g and 22g bd intima ii¿ iv catheter.Neither sample had been used and there was no evidence of any abnormalities.Both the test of bi aseptic and the eo residue test passed with no errors noted.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode and an absolute root cause for this incident cannot be determined.

• Brand Name: BD INTIMA II¿ IV CATHETER
• 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 ; 8015652845
• MDR Report Key: 6759193
• MDR Text Key: 81563109
• Report Number: 3006948883-2017-00031
• 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: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 383407
• Device Lot Number: 6018383
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• 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
• Patient Outcome(s): Other