MAUDE Adverse Event Report: BECTON DICKINSON, S.A. CONNECTOR LUER LOCK C45; INTRAVASCULAR ADMINISTRATION SET

Model Number	515202
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.The customer's address is unknown.(b)(6) has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that connector luer lock c45 leaked.The following information was provided by the initial reporter: material no: 515202; batch no: unknown.It was reported that the phaseal connector leaking when administering sq chemotherapy.Question email inquiry from nurse manager: we are having an issue with the phaseal connector leaking when administering sq chemotherapy.Response spoke with nurse via phone.Verified that they are using the correct phaseal and phaseal injector.Per the phaseal clinical procedures manual, reviewed technique for connecting the phaseal connector to the syringe assembly (pharmacy sends pre-filled chem syringe with injector attached to nurses.Nurses then connect the needle and connector the syringe assembly).Verified that they are performing this technique correctly.Also spoke with pharmacist who provided the product codes.He does not have the lot numbers for the products used.Informed that this information will be sent to product complaints.Emailed case to product complaints.Verbatim: per customer's response on 11/02/2020, "hello, the leak did not occur at any connection.It occurred at the actual head of the needle if that makes sense? thanks, per customers response on 10/22/2020, this occurred on (b)(6) 2020.There were no physical injuries other than a portion of the dose leaking.I have worked with the phaseal for years.I truly believe it is just too much pressure for a 15 ml sq injection.I ensured each connection was secure, that was not the issue.When i took the phaseal off, the duration of the injection went smoothly, with no leaking noted with the remaining 9-10 ml.I disposed of the injection per protocol, so i do not have the actual injection for you to reference.
Additional Manufacturer Narrative
H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.
Event or Problem Description
It was reported that connector luer lock c45 leaked.The following information was provided by the initial reporter: material no: 515202 batch no: unknown it was reported that the phaseal connector leaking when administering sq chemotherapy.Question email inquiry from nurse manager: we are having an issue with the phaseal connector leaking when administering sq chemotherapy.Response spoke with nurse via phone.Verified that they are using the correct phaseal and phaseal injector.Per the phaseal clinical procedures manual, reviewed technique for connecting the phaseal connector to the syringe assembly (pharmacy sends pre-filled chem syringe with injector attached to nurses.Nurses then connect the needle and connector the syringe assembly).Verified that they are performing this technique correctly.Also spoke with pharmacist who provided the product codes.He does not have the lot numbers for the products used.Informed that this information will be sent to product complaints.Emailed case to product complaints.Verbatim: per customer's response on 11/02/2020 hello, the leak did not occur at any connection.It occurred at the actual head of the needle if that makes sense? thanks, hello, the leak did not occur at any connection.It occurred at the actual head of the needle if that makes sense? thanks, per customers response on 10/22/2020 this occurred on friday, (b)(6) 2020.There were no physical injuries other than a portion of the dose leaking.I have worked with the phaseal for years.I truly believe it is just too much pressure for a 15 ml sq injection.I ensured each connection was secure, that was not the issue.When i took the phaseal off, the duration of the injection went smoothly, with no leaking noted with the remaining 9-10 ml.I disposed of the injection per protocol so i do not have the actual injection for you to reference.

• Brand Name: CONNECTOR LUER LOCK C45
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10832237
• Report Number: 3003152976-2020-00497
• Device Sequence Number: 2829352
• Product Code: ONB
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (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): 11/13/2020

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 Model Number: 515202
• Device Catalogue Number: 515202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1