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

Catalog Number	385110
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter e-mail: 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.
Event or Problem Description
It was reported that the bd¿ prn adapter leaked from the luer connection during use.The following information was provided by the initial reporter, translated from japanese: "according to the customer's report, leakage from the rubber component was observed.No information on what leaked was provided in the initial report.".
Additional Manufacturer Narrative
H6: investigation summary: the sample submitted by the facility could not be returned to the manufacturing facility, due to current customs law in china.High-resolution microscopic images were taken of the component's surface and submitted to the engineers at the manufacturing facility.Using the images our engineers were not able to identify any damage that would have lead to a leak.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.A device history review could not be completed as no batch number was provided.H3 other text : see h10.
Event or Problem Description
It was reported that the bd¿ prn adapter leaked from the luer connection during use.The following information was provided by the initial reporter, translated from japanese: "according to the customer's report, leakage from the rubber component was observed.No information on what leaked was provided in the initial report.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15575798
• Report Number: 3014704491-2022-00476
• Device Sequence Number: 6158427
• Product Code: FOZ
• UDI-Device Identifier: 00382903851102
• UDI-Public: (01)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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2022

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 11/06/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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