MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD INTROSYTE-N; CATHETER INTRODUCER

Model Number	384021
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the outer box information stated "made in usa", while the bd introsyte-n¿ packaging stated "made in (b)(6)".The following information was provided by the initial reporter: "i recently obtained a box of this product 384021, lot # 0164202.Visually inspecting it, the outer box states "made in usa".When i opened the box and looked at an individually packaged needle, it states "made in (b)(6)".Lot numbers match on both inner and outer packaging.".
Additional Manufacturer Narrative
H6: investigation summary: a physical sample was not available for investigation but 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 was opened by the manufacturing facility to correct this issue.Bd has issued capa 1874212 regarding the incorrect country of origin on the shipper label and is currently in the effectiveness review stage.H3 other text : see h10.
Event or Problem Description
It was reported that the outer box information stated "made in usa", while the bd introsyte-n¿ packaging stated "made in mexico".The following information was provided by the initial reporter: "i recently obtained a box of this product 384021, lot # 0164202.Visually inspecting it, the outer box states "made in usa".When i opened the box and looked at an individually packaged needle, it states "made in mexico".Lot numbers match on both inner and outer packaging.".

• Brand Name: BD INTROSYTE-N
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 11276858
• Report Number: 9610847-2021-00056
• Device Sequence Number: 14125519
• Product Code: DYB
• UDI-Device Identifier: 50382903840217
• UDI-Public: 50382903840217
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 01/12/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1