MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL CONNECTOR LUER LOCK (C35); INTRAVASCULAR ADMINISTRATION SET

Model Number	515200
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/10/2020
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.(b)(4).
Event or Problem Description
It was reported that foreign matter was found in 221 bd phaseal¿ connector luer lock (c35) devices before use during an inspection.The following information was provided by the initial reporter, translated from (b)(6) to english: "foreign matter confirmed during in-process inspection".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-10-20.H6: investigation summary two hundred and eleven samples were provided to our quality team for investigation.Upon visually inspecting the product, black particles were observed to be embedded within the connector body on all samples.A device history review was performed for the reported lot 2001115, no deviations or non-conformances were identified during the manufacturing process that could have contributed to embeded particles within the product.Final products are subjected to both visual and functional inspections throughout manufacturing and machines undergo proper maintenance and clearly define cleaning according to procedure.While we could not identify a direct issue, it was determined the particles likely generated during the molding process as a result of dirt accumulating within the injection machine, them becoming embedded within the connector as observed on the returned product.
Event or Problem Description
It was reported that foreign matter was found in 221 bd phaseal¿ connector luer lock (c35) devices before use during an inspection.The following information was provided by the initial reporter, translated from japanese to english: "foreign matter confirmed during in-process inspection".

• Brand Name: BD PHASEAL CONNECTOR LUER LOCK (C35)
• 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: 10656102
• Report Number: 3003152976-2020-00439
• Device Sequence Number: 11706630
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 12/31/2023
• Device Model Number: 515200
• Device Catalogue Number: 515200
• Device Lot Number: 2001115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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