MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL INJECTOR LUER LOCK N35C; INTRAVASCULAR ADMINISTRATION SET

Model Number	515004
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd phaseal¿ injector luer lock n35c had foreign matter on it.This was discovered before use.The following information was provided by the initial reporter: when they opened the packing with injectors they discovered that is was strange black spots on it.
Additional Manufacturer Narrative
H.6.Investigation summary no photos or physical samples that display the reported condition were provided for investigation.Three retained samples of lot 1909111 were used for additional evaluation.Upon inspecting the products using magnification, a black spot was found on the needle housing of one of the samples.A device history record review did not reveal any documented quality issues during the production of lot number 1909111 that could have contributed to this incident.A maintenance order was carried out during the molding process of the needle housing, cleaning the screw chamber from mold.After the order was completed, verification was performed to ensure there was no dirt or particles observed on the injector samples.The particle observed was identified to be dirt that accumulated in the mold and embedded in the needle housing.Based on our investigation, it was determined the product reported was likely related to this incident, the affected samples not properly identified during the inspections that were performed.Machines undergo routine maintenance and clearly defined cleaning according to procedure.Manufacturing personnel have been notified of this incident to increase awareness of this matter.Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported that bd phaseal¿ injector luer lock n35c had foreign matter on it.This was discovered before use.The following information was provided by the initial reporter: when they opened the packing with injectors they discovered that is was strange black spots on it.

• Brand Name: BD PHASEAL INJECTOR LUER LOCK N35C
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9717813
• Report Number: 3003152976-2020-00060
• Device Sequence Number: 679325
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 515004
• Device Catalogue Number: 515004
• Device Lot Number: 1909111
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other