MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ INSYTE WINGED VIALON-E; CATHETER

Catalog Number 388534

Device Problem Device Contamination With Biological Material (2908)

Patient Problem Sepsis (2067)

Event Date 06/05/2018

Event Type  Injury  

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 that an bd¿ insyte winged vialon-e contributed to blood stream infection.Unknown medical intervention.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The nonconformance cannot be confirmed.The certificate of sterility was also reviewed and showed that batch 5233189 was sterilized and passed the sterility test.A device history record review showed no non-conformances associated with this issue during the production of this batch.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.The complaint will be reopened if the sample is returned for investigation.

Event Description

It was reported that an bd¿ insyte winged vialon-e contributed to blood stream infection.Unknown medical intervention.

• Brand Name: BD¿ INSYTE WINGED VIALON-E
• Type of Device: 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: 7642842
• MDR Text Key: 112499282
• Report Number: 8041187-2018-00215
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• 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: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 388534
• Device Lot Number: 5233189
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 06/06/2018
• Supplement Dates FDA Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2015
• 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