MAUDE Adverse Event Report: LIEBEL-FLARSHEIM ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)

Model Number 900103

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: complaint incident: a customer in china contacted l-f guerbet's regional distributor, claiming that while using l-f's 150ml single-use syringe, catalog number 900103, lot c027302g, that the tubing set was difficult to remove from the syringe after the injection.Additionally, the customer stated that the amount of contrast media needed for this particular procedure is approximately 200ml, therefore, their intentions were to reuse the single-use 150ml syringe to complete the procedure.The inability to disconnect the tubing set inhibited the reuse of the syringe.Investigation: although no samples were returned for investigation, the customer did submit photos of the tubing sets used.Based on the photos sent, it was discovered that the customer was using an incompatible competitor's tubing set with the syringe.The injector's instructions for use state to only use approved syringes and tubing sets as others could leak or cause damage to the product.Additionally, the reuse of the 150ml syringe to inject 200ml of solution is considered off-label use of the syringe and could put the patient at increased risk.The instructional insert sheet, as well as the primary packaging of the 900103 150ml syringe both state that the product is not to be reused.Conclusion: due to the off-label use of the syringe, as well as the use of incompatible tubing sets, this complaint cannot be attributed to the syringe or the manufacturing process used to produce it.Therefore, no corrective actions are anticipated at this time.It was recommended that the customer use a 200ml syringe, l-f catalog number 900105, to complete a 200ml procedure, as well as compatible tubing as per the injector's operator manual.A review of guerbet's complaint tracking system indicates that this customer submitted 4 such complaints, all at the same time for this same incident, after 5 previous complaints of the same nature.As a result of the first 5 complaints, guerbet sent their applications specialist to the account to explain best practices.Additionally, guerbet's complaint tracking system indicated that no similar complaints have been submitted by any other customers.Root / probable cause code: personnel - performance - failed to follow procedure.Root / probable cause summary.The root cause is off-label use and use with incompatible tubing.There is no need for capa for this issue due to the root cause determination.Disposition summary.Lot remained in use.

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2021.The customer reported that the connection between the syringe and the tubing cannot be separated.The injector used in the department of cardiology, (b)(6) hospital is the lf brand.From april 2021, the clinical department reported that when performing surgery, the amount of contrast medium required by a patient is more than 150ml, so the contrast medium needs to be repeatedly sucked during the operation.The doctor found that the syringe and tubing could not be separated when re-absorbing the contrast agent.In order to avoid severely affecting the progress of the operation, doctor use connecting tubing to suck contrast.Due to this ,the surgery has not been finished.Patient has not been injured.This type of incident has occurred 7 times so far.

• Brand Name: ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)
• Type of Device: ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; cincinnati, OH 45237
• MDR Report Key: 11870358
• MDR Text Key: 264088443
• Report Number: 1518293-2021-00014
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K963071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900103
• Device Lot Number: C027302G
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1