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

Catalog Number 382412

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 there was foreign matter with a bd angiocath¿ plus iv catheter.The following information was provided by the initial reporter: tube is not smooth like foreign material on the tube.

Manufacturer Narrative

Investigation summary: 1 photo was received, fm on cannula was observed.1 actual sample was returned for investigation, a clear fm was observed on the cannula.A review of the device history record revealed no irregularities during the manufacture of the reported lot.The complaint is confirmed and product is not meeting the requirement.The fm was subjected to ftir analysis.The results showed that the spectrum of the fm matched with spectrum of silicone.The reported defect could be originated from tipping process.During the investigation, it was noticed that there are solidified silicones at the edges of the lube tank holder.The solidified silicone could have transferred to the catheter during the lubrication process.

Event Description

It was reported that there was foreign matter with a bd angiocath¿ plus iv catheter.The following information was provided by the initial reporter: tube is not smooth like foreign material on the tube.

• Brand Name: BD ANGIOCATH¿ PLUS IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8601268
• MDR Text Key: 145114495
• Report Number: 8041187-2019-00363
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

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?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 382412
• Device Lot Number: 8300622
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other