MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INTROSYTE¿ PRECISION INTRODUCER; INTRAVASCULAR CATHETER

Catalog Number	384040
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2018
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 that "approximately 3cm" of the bd introsyte¿ precision introducer was found broken after opening up the material during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "when opening the material, it was noticed that it was approximately 3cm broken.".
Additional Manufacturer Narrative
H.6.Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record was performed and no quality issues were found during production.
Event or Problem Description
It was reported that "approximately 3cm" of the bd introsyte¿ precision introducer was found broken after opening up the material during use.The following information was provided by the initial reporter, translated from portuguese to english: "when opening the material, it was noticed that it was approximately 3cm broken.".

• Brand Name: BD INTROSYTE¿ PRECISION INTRODUCER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8728220
• Report Number: 1710034-2019-00659
• Device Sequence Number: 2637028
• Product Code: DYB
• UDI-Device Identifier: 50382903840408
• UDI-Public: 50382903840408
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K020834
• 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): 07/18/2019

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: 10/31/2020
• Device Catalogue Number: 384040
• Device Lot Number: 7299824
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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