MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ Y-SITE CONNECTOR C80; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
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.H.3.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 while using the bd phaseal¿ y-site connector c80 broke.The following was translated from french to english: i have to administer chemotherapy in a syringe (vincristrine).The device is made with a connection made up of two branches, one for chemo and one for inserting the rinsing syringes.So i push in a first rinsing syringe, unscrew it to put in a second.The screw thread breaks, and the rinse flows into the compress below.For this chemotherapy, our protocol is to carry out a large rinse.The child could have not received his chemo correctly.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one photo along with the physical sample was provided to our quality team for evaluation.The product was visually inspected, no evidence of damage or a crack was observed.Functional testing was performed, passing liquid through the system into an iv bag and withdrawing back into a syringe, in all evaluations the product functioned as intended and no leakages occurred.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.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.Based on the quality team's investigation, and given the returned sample did not identify any issues related to the reported incident, a root cause cannot be identified at this time.Complaints received for this device and reported condition will 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 while using the bd phaseal¿ y-site connector c80 broke.The following was translated from french to english: i have to administer chemotherapy in a syringe (vincristrine).The device is made with a connection made up of two branches, one for chemo and one for inserting the rinsing syringes.So i push in a first rinsing syringe, unscrew it to put in a second.The screw thread breaks, and the rinse flows into the compress below.For this chemotherapy, our protocol is to carry out a large rinse.The child could have not received his chemo correctly additional information from customer: no, the luer connector did not break or disconnect.There is a crack on the thread of the y site connector.

• Brand Name: BD PHASEAL¿ Y-SITE CONNECTOR C80
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17831392
• Report Number: 3003152976-2023-00423
• Device Sequence Number: 14300315
• Product Code: ONB
• UDI-Device Identifier: 00382905153044
• UDI-Public: (01)00382905153044
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: Health Professional
• Device Catalogue Number: 515304
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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