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

Model Number 384021

Device Problems Break (1069); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

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 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 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.".

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
• Type of Device: 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
• MDR Text Key: 230676507
• Report Number: 9610847-2021-00058
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 50382903840217
• UDI-Public: 50382903840217
• Combination Product (y/n): N
• PMA/PMN Number: K020834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 384021
• Device Catalogue Number: 384021
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1