MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 393226

Device Problems Break (1069); Device Fell (4014)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.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 placement of a bd venflon¿ pro safety peripheral safety iv catheter the needle broke and remained in the vein.The patient was taken to the emergency room via ambulance.An echo was done to determine placement of the needle, and the patient was taken to the surgery department for further surgical removal of the needle.

Manufacturer Narrative

Investigation summary: 1 actual sample (batch# unknown) and 4 representative samples (batch #8109028-(b)(4) pcs and batch #8051125-(b)(4) pcs) were returned for investigation.Dhr was not performed as the lot number is unknown.Samples returned.Actual sample: the actual sample was subjected to visual inspection of the catheter.A clean cut was observed on the catheter.Actual sample (broken catheter).The manufacturing process was reviewed and there is no process in the manufacturing facilities that could cause this nonconformance.There is a 100% automated vision inspection that would reject the parts that fail the lie distance.A broken catheter would automatically be rejected as the lie distance would be out of specification.Therefore the nonconformance could have occurred out of the manufacturing facilities.Based on the clean cut observed on the broken catheter of the actual returned sample, the sample could probably be cut by sharp object.From the broken edge of the catheter, no stretched phenomenon or elongation of the catheter tubing could be observed to indicate any issue with the tubing material which could have caused the breakage.Representative samples: the 4 representative samples were subjected to visual inspection.All the representative samples passed the acceptance criteria.Investigation conclusion: there is no process in the manufacturing facilities that could cause this nonconformance.There is a 100% automated vision inspection that would reject the parts that fail the lie distance.

Event Description

It was reported that during placement of a bd venflon¿ pro safety peripheral safety iv catheter the needle broke and remained in the vein.The patient was taken to the emergency room via ambulance.An echo was done to determine placement of the needle, and the patient was taken to the surgery department for further surgical removal of the needle.

• Brand Name: BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7938121
• MDR Text Key: 122821082
• Report Number: 8041187-2018-00357
• Device Sequence Number: 1
• Product Code: FPA
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393226
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention