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

Catalog Number 391350

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Phlebitis (2004); Tissue Damage (2104)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 neoflon¿ iv cannula tip was defective and difficult to insert during use, leading to "phlebitis" and "vein damage".The following information was provided by the initial reporter, translated from arabic to english: "many complaint have been raised from the nursing staff due to the hard insertion of the cannula as there was a problem in sharpness of the needle tip which caused many time insertion of many cannulas." phlebitis and vein damage.

Event Description

It was reported that the bd neoflon¿ iv cannula tip was defective and difficult to insert during use, leading to "phlebitis" and "vein damage".The following information was provided by the initial reporter, translated from arabic to english: "many complaint have been raised from the nursing staff due to the hard insertion of the cannula as there was a problem in sharpness of the needle tip which caused many time insertion of many cannulas." phlebitis and vein damage.

Manufacturer Narrative

H.6.Investigation: there is no photo and no sample returned for investigation of this complaint.Based on the investigation of similar complaint, the probable root cause for catheter tip integrity could be due to the peelback of catheter.Capa #81917 was issued to review the tubing material.For the reported phlebitis, as no photo and no sample returned, a review of the past 12 months qn was performed.No qn related to reported defect was raised.The endotoxins test results of this batch was reviewed and is within the acceptance criteria.Therefore, the root cause for phlebitis cannot be determine.

• Brand Name: BD NEOFLON¿ IV CANNULA
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8895030
• MDR Text Key: 156666097
• Report Number: 8041187-2019-00634
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

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: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 391350
• Device Lot Number: 7138164
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other