MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INTROSYTE-N; CATHETER INTRODUCER

Model Number	384031
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2020
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 the bd introsyte-n¿ introducer was found cracked and damaged before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "crack, breakage of the product or part of it (introducer).".
Event or Problem Description
It was reported that the bd introsyte-n¿ introducer was found cracked and damaged before use.The following information was provided by the initial reporter, translated from portuguese to english: "crack, breakage of the product or part of it (introducer).".
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the photographs submitted for evaluation.Bd received four photographs.The photographs revealed what appeared to be fraying of the introducer.This type of damage may occur in either the manufacturing process or in the user environment.During manufacturing, misalignment could take place causing the damage observed.The photos provided for this incident did not present sufficient evidence to establish a definite root cause.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

• Brand Name: BD INTROSYTE-N
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10034220
• Report Number: 1710034-2020-00292
• Device Sequence Number: 2938186
• Product Code: DYB
• UDI-Device Identifier: 50382903840316
• UDI-Public: 50382903840316
• 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): 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2021
• Device Model Number: 384031
• Device Catalogue Number: 384031
• Device Lot Number: 8178650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 06/25/2020
• 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