MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PRN LUER SLIP ADAPTER .75IN; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385110
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd prn luer slip adapter.75in leaked it was reported that bd prn adaptor luer slip 19mm short (385110) blood leaked out from the rubber joining.
Additional Manufacturer Narrative
1.Returned sample analysis.1- due to customs policy limit, overseas products cannot be sent to suzhou plant.Only returned pictures.2- observed the returned pictures, there is residual transparent substance on the surface of the product, no other anomalies were observed.2.Review batch record information.1- the complaint lot#3286513 was produced in the prn automatic assembly line, the production date is 2023-11, and the m860 packaging machine was packaged in 2023-11, and the batch of products totaled 126.4k.2- check the process inspection and shipment inspection report of this batch of products.The test results meet the product standards and there is no abnormality.3- check the production records and machine maintenance of this batch of products, and there are no abnormalities, deviations or rework activities.3.Retained sample analysis: performed function test on the retained sample that is leakage test, rotary the prn connector on the standard luer connector, then inject the standard water pressure, observe the each connect position whether leakage, the test result is pass, no abnormality was observed.4.Root cause: 1- observed the returned pictures, no abnormality was observed.2-performed the function test on the retained samples, no abnormality on the retained sample based on the above, the root cause cannot be confirmed.5.The plant continue pay attention to this defect.
Event or Problem Description
No additional information provided.

• Brand Name: BD PRN LUER SLIP ADAPTER .75IN
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20002326
• Report Number: 3002601200-2024-00390
• Device Sequence Number: 4953723
• Product Code: FPA
• UDI-Device Identifier: 30382903851103
• UDI-Public: (01)30382903851103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K933467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024

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: 3286513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown