MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXT SET W/ VLV PORT & LL; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	30207E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd ext set w/ vlv port & ll the set detached and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: extension set fall apart with no tension on line.Break occurred at junction of line and side arm.Observed blood leaking out of broken port line.No harm to patient.Potential blood loss or air embolus occurred on two occasions, on two different wards, but wasn't able to provide further information to this.On these two different occassions, the nursing staff using extension set on patient noticed when connected, it was causing leaking and blood to run back into the line.They disposed of the affected extension set and used another.
Event or Problem Description
Added on 04 oct 2023 (b)(6) incident occurred post operation, extension set connected to cvc.Extension set fall apart with no tension on line.Break occurred at junction of line and side arm.Observed blood leaking out of broken port line.No harm to patient.Potential blood loss or air embolus.Occurred on two occasions, on two different wards, but wasn't able to provide further information to this.On these two different occasions, the nursing staff using extension set on patient noticed when connected, it was causing leaking and blood to run back into the line.They disposed of the affected extension set and used another.
Additional Manufacturer Narrative
The mdr is being submitted as a correction to the initial.This complaint is being cancelled due to it being a duplicate.Submission was already completed for this customer's complaint in mfr report # 9616066-2023-02044 for bd complaint (b)(4) (which is the original complaint).

• Brand Name: BD EXT SET W/ VLV PORT & LL
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17927054
• Report Number: 9616066-2023-02077
• Device Sequence Number: 20528698
• Product Code: FPA
• UDI-Device Identifier: 37613203011502
• UDI-Public: (01)37613203011502
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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 Expiration Date: 02/09/2026
• Device Catalogue Number: 30207E
• 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: 09/29/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• 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