MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H10; INTRAVASCULAR CATHETER

Catalog Number 383556

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device brand name: bd nexiva¿ closed iv catheter system ¿ single port with maxzero¿ needleless connector 20 ga 1.00 in a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system ¿ single port with maxzero¿ needleless connector 20 ga 1.00 in experienced difficult safety mechanism/needle disengagement/removal.The following information was provided by the initial reporter we just had a nurse in the ed put an iv in a pt.It would not release after inserted so she could threat the catheter.Reference number 383556, lot 0014645.It sounds like the safety mechanism did not work.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system ¿ single port with maxzero¿ needleless connector 20 ga 1.00 in experienced difficult safety mechanism/needle disengagement/removal.The following information was provided by the initial reporter we just had a nurse in the ed put an iv in a pt.It would not release after inserted so she could threat the catheter.Reference number 383556, lot 0014645.It sounds like the safety mechanism did not work.

Manufacturer Narrative

The following fields were updated due to additional information: concomitant products.Device available for eval?: yes.Concomitant products.Returned to manufacturer on: 2/22/2021.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one used unit with the needle pulled back but still attached to the winged adapter.The reported defect was confirmed.During the microscopic examination of the unit, it was observed that deformed plastic from the tip shield was preventing the v-clip from moving to the open position.This damage would prevent the needle assembly from decoupling from the winged adapter.Based on the location of the damage, the defect most likely originated during the manufacturing process.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

• Brand Name: SEE H10
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11441322
• MDR Text Key: 238596026
• Report Number: 1710034-2021-00174
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 383556
• Device Lot Number: 0014645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1