MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON¿ PERIPHERAL IV CATHETER; INTRAVASCUALR CATHETER

Catalog Number 391350

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 05/30/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd neoflon¿ peripheral iv catheter the catheter was unable to properly be inserted.There was no report of patient impact.The following information was provided by the initial reporter: current in use cannula is not fully inserted into the vein.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 27-jun-2022 h6: investigation summary two photos and two representative samples were received from batch 9144971 by our quality team for evaluation.From the photos, a 24g neoflon product in the unit package and a top web of batch 9144971.Two representative samples were subjected to visual inspection, tip od measurement, and bevel angle measurement.All samples passed inspection, and no abnormalities were observed.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the verbatim, the probable root cause for the reported defect could be catheter peel back issues due to the tubing material.A trend for the peelback issue has been identified for this product line.

Event Description

It was reported while using bd neoflon¿ peripheral iv catheter the catheter was unable to properly be inserted.There was no report of patient impact.The following information was provided by the initial reporter: current in use cannula is not fully inserted into the vein.

• Brand Name: BD NEOFLON¿ PERIPHERAL IV CATHETER
• Type of Device: INTRAVASCUALR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14828253
• MDR Text Key: 303027741
• Report Number: 8041187-2022-00333
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 391350
• Device Lot Number: 9144971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1