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 Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The reported lot # [b164202] was not found for the reported catalog # [384021].Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the bd introsyte-n" was "plugged" before use and one of the wings broke.The following information was provided by the initial reporter, translated from french to english: "introducer plugged before use" "breakage of one of the wings of the introducer when peeled off the two parts.".
Event or Problem Description
It was reported that the bd introsyte-n¿ was "plugged" before use and one of the wings broke.The following information was provided by the initial reporter, translated from french to english: "introducer plugged before use." "breakage of one of the wings of the introducer when peeled off the two parts.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 0164202.D.4.Medical device expiration date: 5/31/2023.H.4.Device manufacture date: 6/22/2020.D.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation: our quality engineer inspected the photo submitted for evaluation.When the sample package arrived at our bd facility the package was found to be empty, so no sample was available for the investigation.The reported issue was confirmed upon inspection of the photo.Bd was able to determine the root cause of the failure to be related to our supplier and they have been notified of the failure.A review for introducer defective / damaged could not be conducted since there was no lot number associated with that failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of wings defective / damaged with lot # regarding item #384021 h3 other text : see h.10.

• 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: 11285968
• Report Number: 9610847-2021-00058
• Device Sequence Number: 14500246
• Product Code: DYB
• UDI-Device Identifier: 50382903840217
• UDI-Public: 50382903840217
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/21/2021

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 Model Number: 384021
• Device Catalogue Number: 384021
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1