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

Catalog Number 388412

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Test Result (2695)

Event Date 07/15/2015

Event Type  Injury  

Event Description

It was reported that a pt pulled out a bd insyte iv catheter by his/herself and in doing so, the catheter broke.It was unk if the broken piece of catheter remained inside the pt.The pt received an x-ray but it is unk if the catheter was found.Additional info regarding the pt's medical treatment has not been provided by the customer.

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Manufacturer Narrative

The device manufacture date is unknown as a lot number was not provided for this incident.Results: one used sample was returned for evaluation.A microscopic evaluation revealed that the catheter tubing had been cut at the area of the break.A review of the device history record cannot be performed as a lot number for this incident was not provided.Conclusion: an absolute root cause for this incident cannot be determined.However, our quality engineer notes that the catheter tubing was most likely cut by a sharp object outside of the manufacturing facility.

Event Description

It was reported that a patient pulled pulled out a bd insyte iv catheter by his/herself and in doing so, the catheter broke.It was unknown if the broken piece of catheter remained inside the patient.The patient received an x-ray but it is unknown if the catheter was found.Additional information regarding the patient's medical treatment has not been provided by the customer.

• Brand Name: BD INSYTE¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 4960985
• MDR Text Key: 21937715
• Report Number: 2243072-2015-00143
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K942045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,other,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 388412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 07/31/2015
• 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
• Patient Outcome(s): Required Intervention