MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CANNULA WITH BD VIALON¿ BIOMATERIAL; IV CONVENTIONAL CANNULA

Catalog Number	381247
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte¿ iv cannula with bd vialon¿ biomaterial contained foreign matter.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: (b)(4) representative samples were received in sealed package.All the samples were subjected to visual inspection.No fm or other abnormalities was observed.However, thicker lube was observed on cannula tip for some of the samples.All samples were subjected to penetration test.Test results showed that both penetration force and drag force were within specifications.No abnormalities was observed on the samples and samples passed the penetration test.A review of the device history record revealed no irregularities during the manufacture of the reported lot #.
Event or Problem Description
It was reported that bd insyte¿ iv cannula with bd vialon¿ biomaterial contained foreign matter.No serious injury or medical intervention was reported.

• Brand Name: BD INSYTE¿ IV CANNULA WITH BD VIALON¿ BIOMATERIAL
• Common Device Name: IV CONVENTIONAL CANNULA
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8029942
• Report Number: 8041187-2018-00401
• Device Sequence Number: 1421431
• Product Code: FOZ
• UDI-Device Identifier: 00382903812479
• UDI-Public: 00382903812479
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 381247
• Device Lot Number: 8018397
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other