MAUDE Adverse Event Report: BD (SUZHOU) BD¿ PRN ADAPTER; INTRAVASCULAR CATHETER

Catalog Number	385110
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd¿ prn adapter disconnected from the needle.The following information was provided by the initial reporter, translated from japanese: "this report is about disconnection of the product from the needle.The customer claims that disconnections occur frequently.".
Additional Manufacturer Narrative
H.3.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¿ prn adapter disconnected from the needle.The following information was provided by the initial reporter, translated from japanese: "this report is about disconnection of the product from the needle.The customer claims that disconnections occur frequently.".
Additional Manufacturer Narrative
H.6.Investigation summary: a device history review was conducted for lot number 2319991.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, 106 unopened samples were submitted to aid in our investigation.Unfortunately, due to current customs law in china, the devices could not be submitted to the manufacturing facility for functional testing.In lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: BD¿ PRN ADAPTER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17740538
• Report Number: 3014704491-2023-00553
• Device Sequence Number: 12446631
• Product Code: FOZ
• UDI-Device Identifier: 00382903851102
• UDI-Public: 00382903851102
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K933467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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 Catalogue Number: 385110
• Device Lot Number: 2319991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/22/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown