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

Catalog Number 391350

Device Problems Difficult to Insert (1316); Use of Device Problem (1670); Mechanics Altered (2984); Positioning Problem (3009)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during use a bd neoflon¿ iv cannula malfunctioned as "on (b)(6) 2018, the eye department was to carry out bilateral lacrimal sound exploration in general anesthesia in an (b)(6) baby.The anesthesia was inhaled with sevoflurane.As standard, a venous access should then be placed.Unfortunately this was not possible after several (4) attempts.The flexulas from bd neoflon could not be placed in the peripheral veins.We found that the plastic part of the venous indwelling cannula pushed back ("dripped") over the steel cannula when it entered the skin/subcutaneous tissue.Since the use of larger venous indwelling cannulas was not anatomically possible for our small patient, the operation had to be discontinued, much to the chagrin of the parents and the surgeon".

Manufacturer Narrative

Investigation summary: no samples displaying the condition reported are available for examination.We were unable to fully investigate this incident.A review of the device history record revealed no irregularities during the manufacture of the reported lots.Investigation conclusion: there are no returned samples or photos for investigation.Hence, root cause not able to establish.

Manufacturer Narrative

Additional information was received for the medical device lot number(s).The following field(s) have been updated: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7088170, medical device expiration date: 2022-03-31, device manufacture date: 2017-04-28.Medical device lot #: 7165108, medical device expiration date:2022-06-30, device manufacture date: 2017-07-11.

• 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: 7492497
• MDR Text Key: 107917874
• Report Number: 8041187-2018-00146
• 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,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 391350
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 MO