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

Catalog Number 391350

Device Problem Leak/Splash (1354)

Patient Problems Skin Discoloration (2074); Swelling (2091)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter phone #: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that after injection when the catheter was being removed resistance was felt and discovered that the needle pierced through the catheter with a bd neoflon¿ iv cannula.The following information was provided by the initial reporter, translated from (b)(6) to english: after punctured to the child patient, the injected part became blue purple and swollen.When the hcp removed the catheter, s/he felt resistance.S/he confirmed the removed needle pierced thru the catheter.

Manufacturer Narrative

H.6.Investigation: pictures and sample were provided for evaluation of the reported failure, which was confirmed.The probable root cause could be due to the handling during product application.From the verbatim, the needle pierce through catheter could have happened during product punctured into vein.The manufacturing process has been reviewed.There is an automated vision inspection system that can detect and reject product not meeting the lie distance requirement.If the needle pierced through catheter in the manufacturing process, the defective part would be rejected by the automated vision inspection system as the product will not have any lie distance.It would also not be possible to use the product if needle was pierced through catheter before use.No dhr review was performed as the batch number is unknown.H3 other text : see h.10.

Event Description

It was reported that after injection when the catheter was being removed resistance was felt and discovered that the needle pierced through the catheter with a bd neoflon¿ iv cannula.The following information was provided by the initial reporter, translated from japanese to english: after punctured to the child patient, the injected part became blue purple and swollen.When the hcp removed the catheter, s/he felt resistance.S/he confirmed the removed needle pierced thru the catheter.

• 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: 9324674
• MDR Text Key: 178611835
• Report Number: 8041187-2019-00920
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391350
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other