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

Catalog Number 391350

Device Problem Material Deformation (2976)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Initial reporter addr: (b)(6).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0266048, medical device expiration date: 2025-08-31, device manufacture date: 2020-09-22.Medical device lot #: 9053732, medical device expiration date: 2024-02-29, device manufacture date: 2019-02-22.Investigation summary: three photos, three representative samples, and seven used samples were received by our quality team for evaluation.From the photo, a defect sample with the cannula pierced through the catheter a defect sample with peelback on the catheter tip was observed.The representative samples were subjected to visual inspection, tip od measurement, bevel angle measurement and penetration testing.All samples passed inspection and no abnormalities were observed.The used samples were subjected to visual inspection, all seven samples were observed with peelback, and one sample was observed with the needle pierced through the catheter.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.There is a 100% online vision inspection for lie distance.If the needle pierced through the catheter during the manufacturing process, the sample will be rejected by the machine.The needle could have pierced through the catheter when the user accidently reinserted the needle back to the catheter during the penetration as the catheter peelback occurred.The probable roto cause for peelback could be due to the tubing material.A trend for the peelback issue has been identified for this product line.The appropriate personnel have been notified of this complaint.We have funded a project to examine how to further increase the robustness of the bd neoflon device and prevent future occurrences of this type.Customer complaint trends will also continue to be evaluated on a monthly basis.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: 3 returned representative samples pass the visual inspection, tip od measurement, bevel angle measurement and penetration test.All samples passed the acceptance criteria, no abnormality was observed.Needle pierced through catheter was also observed on one of the used sample.There is a 100% online vision inspection for lie distance.If the pierce through happens in the manufacturing process, the sample will be rejected by the machine.The needle pierced through could had happened when user accidentally reinsert the needle back to catheter during penetration as the catheter peelback occurred.Peelback was observed on all the 7 used sample.The probable root cause for peelback could be due to tubing material.Capa# (b)(4) was initiated to address the issue.Complaint trend would be monitored.

Event Description

It was reported that a bd neoflon¿ iv cannula experienced the needle piercing through the catheter during catheter introduction.The following information was provided by the initial reporter: tried inserting an iv catheter (neoflon 24 g) but the plastic part of the catheter peeled back.This issue happened for multiple times (app.100-120 catheters in total of 4 wards within 4 days.) they also said that the needle did not go through the skin easily, like it was not sharp enough.

• Brand Name: BD NEOFLON¿ IV CANNULA
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12713117
• MDR Text Key: 278835716
• Report Number: 8041187-2021-00934
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 391350
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Date Manufacturer Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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