MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD¿ PRN ADAPTER; INTERVASCULAR CATHETER

Catalog Number	385110
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a luer-lock product was mixed into the carton of bd¿ prn adapters.The following information was provided by the initial reporter, translated from (b)(6): "this is a report about a mixed product.The customer reported as follows: in a carton of prn luer slip adapter (cat#385110; lot#0230628), one luer lock product was found.This complaint product was placed in the package with the product information of cat#385110 and lot#1194667.".
Additional Manufacturer Narrative
H.6: investigation summary: in response to the event reported by your facility a device history review was conducted for lot number 0230628.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, a photograph of the reported issue was submitted to aid in our investigation.Our engineers noted that the photograph displayed an opened luer-slip packaging unit and a luer-lock device.During the review of the manufacturing records for both lots , our engineers were able to identify a one-year difference in production dates between these two lots with lot#0230628 being manufactured in september of 2020 and lot#1194667 being manufactured in august of 2021.Similarly the shipment dates of these two lots was separated by one-year.Based on this information our engineers could not determine a production related root cause for the inclusion of the later lot#1194667 in the carton of the earlier lot#0230628, as they could not rule out a mix-up after the product had left the facility.As a precautionary measure we have issued a retrain to our production team to increase awareness of this potential issue.H3 other text : see h.10.
Event or Problem Description
It was reported that a luer-lock product was mixed into the carton of bd¿ prn adapters.The following information was provided by the initial reporter, translated from japanese: "this is a report about a mixed product.The customer reported as follows: in a carton of prn luer slip adapter (cat#385110; lot#0230628), one luer lock product was found.This complaint product was placed in the package with the product information of cat#385110 and lot#1194667.".

• Brand Name: BD¿ PRN ADAPTER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14220133
• Report Number: 3014704491-2022-00160
• Device Sequence Number: 4261067
• 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): 06/13/2022

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 Expiration Date: 09/17/2024
• Device Catalogue Number: 385110
• Device Lot Number: 0230628
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 07/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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