MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA PROTECTOR P28-O; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515063
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd phaseal¿ optima protector p28-o the device was damaged.There was no report of patient impact.The following information was provided by the initial reporter: and we had another incident where the larger protectors are not expanding.This time the protector actually cracked where the protector and syringe connect and sprayed cisplatin into the hood because the air went into the vial and not the protector.Bear in mind this is only happening with the larger protectors and it's not happening every time we utilize them.Here are the steps we are taking: drawing back to anywhere between 30ml to 40ml of air leaving the vial sitting in the hood, directing air into the protector balloon does not expand, therefore giving us "push back" against the syringe this time the push back caused the snapping of the protector and syringe and spraying cisplatin until the vial equalized pressure.
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification the product is not damaged, flow rate, and all critical dimensions meet specifications.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h10.
Event or Problem Description
It was reported while using bd phaseal¿ optima protector p28-o the device was damaged.There was no report of patient impact.The following information was provided by the initial reporter: and we had another incident where the larger protectors are not expanding.This time the protector actually cracked where the protector and syringe connect and sprayed cisplatin into the hood because the air went into the vial and not the protector.Bear in mind this is only happening with the larger protectors and it's not happening every time we utilize them.Here are the steps we are taking: drawing back to anywhere between 30ml to 40ml of air leaving the vial sitting in the hood, directing air into the protector balloon does not expand, therefore giving us "push back" against the syringe this time the push back caused the snapping of the protector and syringe and spraying cisplatin until the vial equalized pressure.

• Brand Name: BD PHASEAL¿ OPTIMA PROTECTOR P28-O
• 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: 17916786
• Report Number: 3003152976-2023-00457
• Device Sequence Number: 14155766
• Product Code: ONB
• UDI-Device Identifier: 00382905150630
• UDI-Public: (01)00382905150630
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/17/2023

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: 515063
• Device Lot Number: UNKNOWN
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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