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

Catalog Number	385110
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the prn was found separated from the bd¿ prn adapter when opening the carton.The following information was provided by the initial reporter, translated from japanese: "this is a report about separation of the rubber cap of prn luer slip adapter.According to the customer's verbatim report, when opening the carton, the rubber cap was found to be separated.".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 28-feb-2023 h6: investigation summary a device history review was conducted for lot number 1194667.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, eleven samples were submitted to our facility for review.During review, the rubber caps to be firmly secured to the adapter body for all eleven units, but the adapter was not nested into the plastic base in three of the units.This nonconformance is most likely the result of vibrations during transportation and is a cosmetic defect that does not affect the functionality of the device.In response to this event we have issued a notification to manufacturing and packaging personnel ensure that adapters are securely nested prior to shipment.H3 other text : see h10.
Event or Problem Description
It was reported that the prn was found separated from the bd¿ prn adapter when opening the carton.The following information was provided by the initial reporter, translated from japanese: "this is a report about separation of the rubber cap of prn luer slip adapter.According to the customer's verbatim report, when opening the carton, the rubber cap was found to be separated.".

• Brand Name: BD¿ PRN ADAPTER
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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: 16375222
• Report Number: 3014704491-2023-00015
• Device Sequence Number: 7544233
• Product Code: FPA
• 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): 03/17/2023

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 Expiration Date: 08/05/2025
• Device Catalogue Number: 385110
• Device Lot Number: 1194667
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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