MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INJECTOR (N35-O MULTI); INTRAVASCULAR ADMINISTRATION SET

Model Number	515053
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
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 the bd phaseal¿ optima injector (n35-o multi) cracked when detaching it from the vial.The following information was provided by the initial reporter: "after pulling the drug into the syringe it broke when she detached the n35 from the vial and it broke.The crack right at the white part at the end of the n35.".
Additional Manufacturer Narrative
H6: investigation summary multiple photos were provided to our quality team for investigation.Through visual inspection, the injector grips were observed to be separated and the injector was completed disassembled.Further evaluation identified grip 2 was cracked.A device history review was performed for lot 2201301, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Fifteen retained sample of the sample lot were used for additional evaluation.The products were inspected and no damage with the grips were identified.Product undergoes a series of visual and functional inspections throughout the manufacturing process, no issues were identified during the inspections performed for the reported lot.Although we cannot identify a direct issue, it was determined the crack likely occurred during the assembly process.A detection system was implemented to verify the grips are properly assembled, discarding any defective product identified, the reported lot was manufactured prior to the implementation of this system.
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n35-o multi) cracked when detaching it from the vial.The following information was provided by the initial reporter: "after pulling the drug into the syringe it broke when she detached the n35 from the vial and it broke.The crack right at the white part at the end of the n35.".

• Brand Name: BD PHASEAL¿ OPTIMA INJECTOR (N35-O MULTI)
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15397003
• Report Number: 3003152976-2022-00409
• Device Sequence Number: 17667936
• Product Code: ONB
• UDI-Device Identifier: 00382905150531
• UDI-Public: 00382905150531
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: 06/30/2024
• Device Model Number: 515053
• Device Catalogue Number: 515053
• Device Lot Number: 2201301
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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