MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE

Model Number 309628

Device Problems Unsealed Device Packaging (1444); Volume Accuracy Problem (1675)

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

Event Date 09/10/2021

Event Type  malfunction  

Event Description

It was reported that 5 bd luer-lok¿ tip syringes had open packaging seals, and 1 syringe had skewed scale markings.The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2021, our company found 3 defects in the inspection process of the batch of syringes".Via bd investigation: "five of the syringes were observed to have red and metallic vendor splice tape in the seal area, which resulted in an open seal for those samples." "one of the two samples was also observed to have horizontal damage on the printed scale, a bent flange, and a severely skewed scale.".

Manufacturer Narrative

Date received by manufacturer: bd was initially made aware of this complaint on 2021-09-10.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional information was later received on 2021-11-19 that changed the reportability determination.Based on the additional information received, this complaint is now considered to be an mdr reportable incident.Investigation summary: nine 1ml luer-lock syringes (p/n 309628) sealed in their blisterpaks from batch #8303696 were received.The samples were visually evaluated.Five of the syringes were observed to have red and metallic vendor splice tape in the seal area, which resulted in an open seal for those samples.One of the two samples was also observed to have horizontal damage on the printed scale, a bent flange, and a severely skewed scale.All conditions observed were non-conforming per product specification.Potential root cause for the open seal is associated with the vendor top web material received.Red sided tape is not adequately detected by the splice sensors on the packaging machine this batch was manufactured.The red tape would pass through undetected which would lead to the defect observed.Potential root cause for the skewed scale defect is associated with the marking process.The following corrective actions have been taken since the manufacture of this batch for the open seal and red splice tape defect: internal procedures have been updated to disallow the use of red tape at our manufacturing site.Buy specifications for the top web packaging have been updated to no longer allow the vendor to use red sided splice tape in their manufacturing process.Internal procedures for challenging splice tape sensors were updated for clarity and to include proper verification examples.The following corrective action has been taken for the bent flange and resulting skewed scale defect: a bent flange sensor was installed on the marking machine.This sensor will stop the machine if it detects a bent flange being processed and reject the affected product upon start-up.Implemented: (b)(6) 2020.Missing component and foreign matter outside of the fluid path conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #8303696 is considered in compliance with our product specification requirements.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD LUER-LOK¿ TIP SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12861487
• MDR Text Key: 281155483
• Report Number: 1213809-2021-00780
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: 8303696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1