MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER; INTRAVASCULAR CATHETER

Model Number 381212

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

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 insyte¿ iv catheter experienced catheter separation from the hub.The following information was provided by the initial reporter: baby had ivc insitu for antibiotics.During routine n/saline flushing, the cannula began to leak.The midwife caring for the baby, removed the tapes and discovered that the plastic cannula had snapped off near the hub.Photos were taken and the length of the cannula was compared to a new cannula to confirm length and ensure no missing parts.

Manufacturer Narrative

H.6.Investigation: two photos were received by our quality team for evaluation.From the photo, the catheter was observed to be broken in a short distance away from the adapter.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.A manufacturing review was performed at the flaring and swage depth measuring station of the isam machine and there is no possible contact point which could cause any damage to the catheter.Also, there is an automated vision system at the assembly machine whereby if there is any broken catheter occurred in the manufacturing process, the defect part would be rejected by the automated vision inspection system as the product will fail the lie distance.This nonconformance could have occurred out of the manufacturing facility during product application.As the actual sample was not returned for evaluation, the root cause could not be established.Dhr was performed, no quality notification was raised for similar nonconformance for the past 12 months.

Event Description

It was reported that the bd insyte¿ iv catheter experienced catheter separation from the hub.The following information was provided by the initial reporter: baby had ivc insitu for antibiotics.During routine n/saline flushing, the cannula began to leak.The midwife caring for the baby, removed the tapes and discovered that the plastic cannula had snapped off near the hub.Photos were taken and the length of the cannula was compared to a new cannula to confirm length and ensure no missing parts.

• Brand Name: BD INSYTE¿ IV CATHETER
• Type of Device: INTRAVASCULAR 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12715514
• MDR Text Key: 281915686
• Report Number: 8041187-2021-00936
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903812128
• UDI-Public: 30382903812128
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151698
• 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: 11/18/2021

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
• Device Operator: Other
• Device Model Number: 381212
• Device Catalogue Number: 381212
• Device Lot Number: 0224296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• 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