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

Catalog Number	381234
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 that before use of the bd¿ insyte the catheter was damaged.Foreign complaint the following information was provided by the initial reporter, translated from spanish to english: catheter damaged.
Additional Manufacturer Narrative
Investigation: a device history record review was performed and showed no non-conformances associated with this issue during the production of this batch.Since no samples or photos displaying the condition reported are available for examination, we were unable to fully investigate this incident.
Event or Problem Description
It was reported that before use of the bd¿ insyte the catheter was damaged.Foreign complaint the following information was provided by the initial reporter, translated from spanish to english: catheter damaged.

• Brand Name: BD¿ INSYTE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8516482
• Report Number: 8041187-2019-00303
• Device Sequence Number: 1899735
• Product Code: FOZ
• UDI-Device Identifier: 30382903812340
• UDI-Public: 30382903812340
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: 05/31/2020
• Device Catalogue Number: 381234
• Device Lot Number: 5142320
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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