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

Catalog Number	381244
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that foreign matter described as ¿white residue¿ was found on a bd insyte¿ peripheral venous catheter before use.There was no report of injury or medical interventions.
Additional Manufacturer Narrative
Investigation summary: no samples displaying the condition reported are available for examination.We were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.Investigation conclusion: the nonconformance cannot be confirmed as no sample was returned for investigation.

• Brand Name: BD INSYTE¿ PERIPHERAL VENOUS CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7331288
• Report Number: 8041187-2018-00052
• Device Sequence Number: 231068
• Product Code: FOZ
• UDI-Device Identifier: 30382903812449
• UDI-Public: 30382903812449
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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: 01/31/2021
• Device Catalogue Number: 381244
• Device Lot Number: 6025346
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 04/06/2018
• 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