MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ SINGLE PORT CATHETER; INTRAVASCULAR CATHETER

Model Number	383520
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood leaked from the connection point of the bd nexiva¿ single port catheter flexure tube while administering it.The following information was provided by the initial reporter, translated from (b)(6): "during the administration of foreign blood (ec), leakage occurred at the connection point of the flexure tube.The blood product was connected to the connection port.The blood has leaked at the point where the connection port ends in the "wings" of the flexure tube.The flexure patch was found to be new and uncontaminated.The plaster was also contaminated with blood at the same rate as the blood was dripping.".
Additional Manufacturer Narrative
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 blood leaked from the connection point of the bd nexiva¿ single port catheter flexure tube while administering it.The following information was provided by the initial reporter, translated from german: "during the administration of foreign blood (ec), leakage occurred at the connection point of the flexure tube.The blood product was connected to the connection port.The blood has leaked at the point where the connection port ends in the "wings" of the flexure tube.The flexure patch was found to be new and uncontaminated.The plaster was also contaminated with blood at the same rate as the blood was dripping.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 01-apr-2022.H6: investigation summary: our quality engineer inspected the representative sample submitted for evaluation.Bd received one unopened unit from lot number 1133184.A visual inspection of the extension tubing was performed under magnification.No damage to the extension tubing was identified.A leak test was performed where leakage was not observed.The returned unit provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failure stated in your report.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

• Brand Name: BD NEXIVA¿ SINGLE PORT CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13831203
• Report Number: 1710034-2022-00132
• Device Sequence Number: 910630
• Product Code: FOZ
• UDI-Device Identifier: 30382903835202
• UDI-Public: 30382903835202
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102520
• 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
• Report Date (Section B): 04/18/2022

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: 04/30/2024
• Device Model Number: 383520
• Device Catalogue Number: 383520
• Device Lot Number: 1133184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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