MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INTRODUCER INTROSYTE-N 1.9F 1.9CM; CATHETER INTRODUCER

Model Number	384021
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that introducer introsyte-n 1.9f 1.9cm had incorrect label information.The following information was provided by the initial reporter: "product delivered mentions made in mexico but in our system it says made in usa (also on boxes).".
Additional Manufacturer Narrative
H.6.Investigation: bd was provided with a photo of the issue for evaluation.Our quality engineer reviewed the provided photo and observed that the country of manufacturing was wrong.Both packages should have stated made in mexico.Based off the provided photo, the engineer was able to verify the reported defect.It was determined that this was a packaging issue.An investigation, capa#1874212, has been opened by the manufacturing facility to correct this issue.The packaging dhr for lot 0164202 has been reviewed.One related qn was found for incorrect country of origin.Situation analysis was performed as a result of the qn and a capa was initiated.
Event or Problem Description
It was reported that introducer introsyte-n 1.9f 1.9cm had incorrect label information.The following information was provided by the initial reporter: "product delivered mentions made in mexico but in our system it says made in usa (also on boxes).".

• Brand Name: INTRODUCER INTROSYTE-N 1.9F 1.9CM
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12418754
• Report Number: 1710034-2021-00778
• Device Sequence Number: 3662195
• Product Code: DYB
• UDI-Device Identifier: 50382903840217
• UDI-Public: 50382903840217
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K020834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/27/2021

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: 05/31/2023
• Device Model Number: 384021
• Device Catalogue Number: 384021
• Device Lot Number: 0164202
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1