MAUDE Adverse Event Report: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Model Number	383346
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
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 the bd saf-t-intima" iv catheter safety system separated from the hub after placing it in the external jugular vein.The following information was provided by the initial reporter, translated from (b)(6) to english: "the mother delivered a baby safely at 8:00 on (b)(6) 2021.At 9:03, due to postpartum hemorrhage, a second vein access was needed to be established, so the external jugular vein access was opened.After successful catheteralization of the external jugular indwelling needle, the exposed part of the transparent catheter tube and the green butterfly part were accidentally separated during the removal of the needle." "indwelling position: left external jugular vein.Measures: pull out the problem catheter, replace the indwelling needle (other brands) and the indwelling part (hand and forearm), and reinsert the catheter without delaying the treatment.The woman was not harmed and is in good condition.".
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the 3 photos submitted for evaluation.The reported issue was confirmed upon inspection of the photos.The components separated due to partial solvent within the tubing, which can be caused by manufacturing personnel not following proper procedures.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.A quality alert was generated to inform all manufacturing personnel of the failure to prevent reoccurrence.H3 other text : see h10.
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system separated from the hub after placing it in the external jugular vein.The following information was provided by the initial reporter, translated from chinese to english: "the mother delivered a baby safely at 8:00 on (b)(6) 2021.At 9:03, due to postpartum hemorrhage, a second vein access was needed to be established, so the external jugular vein access was opened.After successful catheteralization of the external jugular indwelling needle, the exposed part of the transparent catheter tube and the green butterfly part were accidentally separated during the removal of the needle." "1.Indwelling position: left external jugular vein.2.Measures: pull out the problem catheter, replace the indwelling needle (other brands) and the indwelling part (hand and forearm), and reinsert the catheter without delaying the treatment.3.The woman was not harmed and is in good condition.".

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12405216
• Report Number: 9610847-2021-00412
• Device Sequence Number: 3549524
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: 30382903833468
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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: 05/31/2023
• Device Model Number: 383346
• Device Catalogue Number: 383346
• Device Lot Number: 9143635
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2019
• 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