MAUDE Adverse Event Report: BECTON DICKINSON BD¿ IV SET CFN120 BP HS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 59012922

Device Problems Structural Problem (2506); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is greater asia.This site is not registered with the fda.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 bd¿ iv set cfn120 bp hs had a "roller clamp control problem: full drop and close there is no middle".No serious injury or medical intervention reported.

Event Description

It was reported that bd¿ iv set cfn120 bp hs had a "roller clamp control problem: full drop and close there is no middle".No serious injury or medical intervention reported.

Manufacturer Narrative

Investigation summary: hanscent did not receive any complaint samples or photos.The affect lot number is 20180209.Additional information received from bd korea: roller clamp didn't control well.There were only two types locking and unlocking.The customer cannot control the flow of fluid with the roller clamp.Retention samples inspection: hanscent randomly inspected 6 pcs of retention samples from lot 20180209 for roller clamp damage, tube distortion or controlling disorder problem, no abnormality was observed.Device history record review: hanscent reviewed manufacturing records such as incoming inspection, roller and clamp injection, tube extrusion and parts assembling, no abnormality was observed.Iv set flow rate: as per iso8536-4:2010 and mfds standard, the flow rate of infusion fluid is required to deliver not less than 1000ml of sodium chloride in 10 mins.Hanscent indicate the iv sets produced have met this requirement during design & development and final product inspection.Iv set flow regulator: as per iso8536-4:2010 and mfds standard, the flow regulator is required to adjust the flow between zero and the maximum, and be able to continuous use throughout an infusion without tubing damaged.Hanscent indicate the iv sets produced have fulfilled the requirement.Roller clamp control test: as hanscent did not receive any samples for investigation, 3 pcs retention samples from lot 20180209 was used to conduct roller clamp controlling test as per iso8536-4:2010.1) iv set flow rate stability analysis: the roller clamp for bd korea iv set is not a precision regulator, the flow rate may change with time, hanscent conducted the stability analysis with the 3 pcs retention samples.The samples were tested with saline solution to measure the flow rate.The results showed that the flow rate could be controlled at a stable flow with maximum variation 5.0%.Hanscent concluded that since the roller clamp used is not precision regulator, and iso8536-4:2010 or mfds did not indicate requirements for flow rate variation, hanscent consider this to be acceptable based on their experience in iv set manufacturing.2) phenomenon observation: no roller clamp moving or locking was observed during the roller clamp controlling test with 3 pcs retention samples.When hanscent adjusted the roller up or down 1 mm-2 mm, the fluid would fall a lot or flow slower for a while and then became stable.Hanscent concluded this due to the roller clamp not a precision control part and the pvc tube needs some time to restore from roller pressure.It was observed that when the gap between roller and clamp is little narrow, the tube might be squeezed a little too much and cannot get restored immediately.This might contribute to the roller clamp controlling difficulty.Root cause: no samples were returned to hanscent.Based on investigation, hanscent concluded the tubing and roller clamp are in compliant with hanscent specification, iso and mfds standard.The cause of the unsteady flow rate was likely due to tube distortion caused during adjusting of roller clamp, and with the roller clamp is not a precision regulator.This results in pressure being build up on the roller, hanscent experience is that a little while is required for the pvc tube to restore from pressure and subsequently the flow rate will be stable.Corrective actions: 1.Hanscent will strengthen the roller clamp injection and assembly processes inspection with one more inspector.2.Hanscent will increase the sampling level of final product inspection on roller clamp function from s-3, aql=1.5 to s-3, aql=1.0 as per iso 2859-1.3.Hanscent will retrain the inspection workers about roller clamp production.The actions are due 03 aug 2018.Preventive actions: 1.Hanscent will monitor roller and clamp production process to ensure both component match within the specification.2.Hanscent will continuously search for improvement opportunity to the roller clamp mold.The actions are due 03 oct 2018.Conclusion: based on investigations, hanscent concluded the roller clamp and tubing are in compliant with hanscent specification, iso and mfds requirement.The cause of the unsteady flow rate was likely due to tube distortion caused during adjusting of roller clamp, and with the roller clamp is not a precision regulator.This results in pressure being build up on the roller, hanscent experience is that a little while is required for the pvc tube to restore from pressure and subsequently the flow rate will be stable.Hanscent will strengthen the processes inspection and final product inspection to insure the roller clamp compliant with regulations, and continue to monitor the production processes and mold investigation to search for improvement opportunity.

• Brand Name: BD¿ IV SET CFN120 BP HS
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7652746
• MDR Text Key: 113017527
• Report Number: 2243072-2018-00419
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/08/2021
• Device Catalogue Number: 59012922
• Device Lot Number: 20180209
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other