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

Model Number 381223

Device Problems Break (1069); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Thrombosis (2100)

Event Date 09/10/2020

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.(b)(4).

Event Description

It was reported that an unspecified number of bd insyte¿ iv catheters experienced device damage/deformation, defective/damaged catheter tips, and holes in catheter.Product defects were noted during use.The following information was provided by the initial reporter: material no: 381223, batch no: 9353123.The brand new catheter would have a burr at the top.The needle went in but did not go in straight.The tip of the catheter was already damaged prior to the lead veterinary technician using it.

Event Description

It was reported that an unspecified number of bd insyte¿ iv catheters experienced device damage/deformation, defective/damaged catheter tips, and holes in catheter.Product defects were noted during use.The following information was provided by the initial reporter: material no: 381223 batch no: 9353123.The brand new catheter would have a burr at the top.The needle went in but did not go in straight.The tip of the catheter was already damaged prior to the lead veterinary technician using it.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 9/21/2020.H.6.Investigation: four unopened unused samples were received by our quality team for evaluation.During visual inspection, it was observed that two of the samples had damaged catheters, confirming the customer experience.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.A review of the manufacturing process shows that the defect may have occurred at the tipping process.A jagged tip or catheter tip integrity is a result of insufficient or no tipping lube.This might be caused due to the lube supply controller not supplying sufficient lube.H3 other text : see h.10.

• Brand Name: BD INSYTE IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10617044
• MDR Text Key: 209597824
• Report Number: 8041187-2020-00634
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903812234
• UDI-Public: (01)30382903812234
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381223
• Device Catalogue Number: 381223
• Device Lot Number: 9353123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other