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

Catalog Number	385110
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd prn luer slip adapter.75in inj site adapter/ connector/ defective damaged according to the customer report there is a snag when gluing the winged needle.Until now, it seems that the winged needle and the prn adapter were firmly attached, but recently it feels like they are floating.It is not clear exactly when this problem started or with which lot, but all three doctors who have used it have noticed it.The lot entered is the one currently in use, and the discomfort is not with just one or two, but with many.It seems like the inner diameter has become smaller, did we change the product recently?.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
1.No samples were returned; no pictures were returned.2.Review batch record information.1-the complaint lot-3258774 was produced in the prn automatic assembly line, the production date is 2023-10, and the m860 packaging machine was packaged in 2023-10, and the batch of products totaled (b)(4).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.4-check eco records, no change for the product.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, the prn and the joint were firmly attached and is not floating.4.Root cause due to no samples were returned, so only performed function test on the retained samples, no abnormality on the test result, it's firmly attached between prn and standard luer connector, and is not floating based on 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 INJ SITE
• 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19976983
• Report Number: 3002601200-2024-00383
• Device Sequence Number: 8586265
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: Health Professional
• Device Catalogue Number: 385110
• Device Lot Number: 3258774
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown