MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY IV CATHETER 20G; INTRAVENEOUS CATHETER

Catalog Number 393264

Device Problem Insufficient Information (3190)

Patient Problem Phlebitis (2004)

Event Date 02/12/2016

Event Type  Injury  

Manufacturer Narrative

The exact device used in this incident is unknown.Two potential lot number have been provided for the reported catalog number.Lot 5265426 medical device expiration date: 9/30/2018 device manufacture date 9/22/2015.Lot 5030237 medical device expiration date: 1/31/2018 device manufacture date 1/30/2015.There is no 510(k) for this device as it is manufactured outside the us and not sold in the us.

Event Description

It was reported that at (b)(6), the patient was treated with unacid (sultamicillin) following phlebitis from the suspect device.Although it is unknown who placed and operated the device, it was reported that the rescue service at the facility places 50% of the vascular access devices.

Manufacturer Narrative

Result - twelve (b)(4) samples were received for evaluation on march 15, 2016, including 6 actual and 6 representative samples.The 6 representative (sealed) samples were visually inspected and noted that the packages are fully sealed with no seal damage.Based on the evaluation, the samples received did not observe any visual defect.The 6 actual (contaminated) samples have been used hence bd is unable to further investigate.Lot 5265426 was produced in october 2015.Lot 5030237 was produced in february 2015.No similar complaint has been received on the lot numbers reported in this incident.A review of the device history revealed no abnormalities or quality notifications during production of the reported lot numbers.No abnormality was reported in the certificate of irradiation and lal for the complaint lots.The preventive maintenance, calibration, and equipment were reviewed and no abnormality was observed that could have influenced the issue.Conclusion - bd was not able to duplicate or confirm the customer¿s indicated failure mode.Based on the evaluation, the representative (sealed) samples received were visually inspected and the packages were fully sealed with no seal damage.Based on the evaluation, the samples received did not observe any visual defect.The actual (contaminated) samples had been used hence bd was unable to further investigate.An absolute root cause for this incident cannot be determined.

• Brand Name: BD VENFLON¿ PRO SAFETY IV CATHETER 20G
• Type of Device: INTRAVENEOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5495042
• MDR Text Key: 40157179
• Report Number: 8041187-2016-00017
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 393264
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention