MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR (P55); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515117
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that plastic was found on the tip of the bd phaseal¿ protector (p55) needle.The following information was provided by the initial reporter, translated from japanese: "this report is about fm on the prastic needle.A plastic piece like a chip was on the tip of the plastic needle.When the product was about to be used, a plastic piece of the same material was on the tip of the plastic needle.There had been one similar case before.".
Additional Manufacturer Narrative
Pr 8814716 follow up mdr for device evaluation: one sample was provided to our quality team for investigation.Through visual inspection, the tip of the protector spike is observed to be bent and has a small burr on the tip, verifying the reported incident.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.As the lot involved in this incident is unknown, a device history review could not be performed and additional retained samples could not be evaluated.While we could not identify a direct issue, it was determined the damage likely occurred during the assembly process when the piece moved between machines.A project has been initiated to reduce any reoccurrence of this issue.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see manufacturer narrative.
Event or Problem Description
It was reported that plastic was found on the tip of the bd phaseal¿ protector (p55) needle.The following information was provided by the initial reporter, translated from japanese: "this report is about fm on the plastic needle.A plastic piece like a chip was on the tip of the plastic needle.When the product was about to be used, a plastic piece of the same material was on the tip of the plastic needle.There had been one similar case before.".

• Brand Name: BD PHASEAL¿ PROTECTOR (P55)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17785190
• Report Number: 3003152976-2023-00400
• Device Sequence Number: 6736176
• Product Code: ONB
• UDI-Device Identifier: 00382905151170
• UDI-Public: (01)00382905151170
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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 Catalogue Number: 515117
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown