MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER C100; INTRAVASCULAR ADMINISTRATION SET

Model Number	515306
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd phaseal¿ infusion adapter c100 cored the rubber stopper in the medication vial during use.This occurred with 3 infusion adapters.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "the hospital site has reported an issue with the phaseal product using the pharmascience brand of bortezomib 3.5 mg powder.The oncology team added a phaseal adaptor and tried to add liquid, which would not push in.Next, they tried a second vial and added phaseal, but no liquid would push in, and the rubber ripped out of the third vial.Healthpro note: the hospital site has indicated that the phaseal adaptor works fine on all other brands of bortezomib.This product concern is only reported for the pms brand of bortezomib 3.5 mg powder.".
Event or Problem Description
It was reported that the bd phaseal¿ infusion adapter c100 cored the rubber stopper in the medication vial during use.This occurred with 3 infusion adapters.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "the hospital site has reported an issue with the phaseal product using the pharmascience brand of bortezomib 3.5 mg powder.The oncology team added a phaseal adaptor and tried to add liquid, which would not push in.Next, they tried a second vial and added phaseal, but no liquid would push in, and the rubber ripped out of the third vial.Healthpro note: the hospital site has indicated that the phaseal adaptor works fine on all other brands of bortezomib.This product concern is only reported for the pms brand of bortezomib 3.5 mg powder.".
Additional Manufacturer Narrative
Correction: b.3.Date of event: 06-jan-2023.
Additional Manufacturer Narrative
H6: investigation summary: no samples or photos received for investigation.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Fragmentation testing is performed during manufacturing to evaluate any particulates generated after ten activations.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
It was reported that the bd phaseal¿ infusion adapter c100 cored the rubber stopper in the medication vial during use.This occurred with 3 infusion adapters.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "the hospital site has reported an issue with the phaseal product using the pharmascience brand of bortezomib 3.5 mg powder.The oncology team added a phaseal adaptor and tried to add liquid, which would not push in.Next, they tried a second vial and added phaseal, but no liquid would push in, and the rubber ripped out of the third vial.Healthpro note: the hospital site has indicated that the phaseal adaptor works fine on all other brands of bortezomib.This product concern is only reported for the pms brand of bortezomib 3.5 mg powder.".

• Brand Name: BD PHASEAL¿ INFUSION ADAPTER C100
• 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 ; 8448235433
• MDR Report Key: 16740500
• Report Number: 2243072-2023-00614
• Device Sequence Number: 20468565
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: 00382905153068
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2023

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 Model Number: 515306
• Device Catalogue Number: 515306
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 01/06/2023; 05/03/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/26/2023; 05/11/2023
• 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