MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ INTRAVASCULAR CATHETER

Catalog Number	381257
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported during use of the bd insyte¿ intravascular catheter, the needle pulled out of the hub.The consumer stated that ¿during surgery, the device needle connection was found to be broken.¿ there was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: one photo and one actual sample in opened packaging were returned for investigation.Our quality engineer inspected the returned sample.The returned actual sample was not from bd tuas.A root cause for the reported defect could not be determined as the product returned was different from the product described on the packaging that was returned.A device history record review showed no non-conformances associated with this issue during the production of the reported batch on the packaging.Based on the photo returned and the visual inspection on the actual sample, the product is not manufactured by bd tuas plant even though the packaging is from bd tuas plant.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.

• Brand Name: BD INSYTE¿ INTRAVASCULAR CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7396320
• Report Number: 8041187-2018-00099
• Device Sequence Number: 1470323
• Product Code: FOZ
• UDI-Device Identifier: 30382903812579
• UDI-Public: 30382903812579
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

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: Other
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 381257
• Device Lot Number: 4120242
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/09/2018
• 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