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

Catalog Number 301073

Device Problems Contamination (1120); Failure to Align (2522); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 the bd luer-lok¿ syringe had particulate contamination, damage, misaligned gasket, print issue and inclusion.There was no report of exposure, serious injury or medical intervention.

Event Description

It was reported that the bd luer-lok¿ syringe had particulate contamination, damage, misaligned gasket, print issue and inclusion.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.Investigation summary: nine loose 3ml assembled syringes were received and reported to be from batch #7313711 (b)(4).The samples were in separate sample bags (five sample bags).Each bag was identified with the complaint#, batch # and description of defect.The samples were visually evaluated.¿particulate¿ ¿ two syringes.One syringe with loose black grease like fm level 1 in size on plunger retaining ring, outside fluid path.Level 1 fm is acceptable per product specification.One syringe with loose black fm level 1 in size on plunger retaining ring, outside fluid path.The fm appears to be a small piece of stopper.Level 1 fm is acceptable per product specification.¿inclusion¿ - one syringe with light brown embedded fm in the barrel wall.The fm appears to be degraded plastic level 1 in size.Level 1 embedded fm is acceptable per product specification.¿damage¿ ¿ two syringes.One syringe has damage to the plunger rod, the plunger rod is folded at about the halfway point.The damage observed is rejectable per product specification.One syringe has glue residue and a portion of a torn label near the barrel step.Small amount of damage was observed to the plunger rod retaining ring, which does not affect its fit, form or function and is acceptable per specification.¿gasket¿ ¿ two syringes.Upon close evaluation, slight stopper angularity was observed.However, it was well within the specification for this product.No defects were confirmed.¿print¿ ¿ two syringes.One syringe has missing print at approximately the 0.5ml grad line to the 1.0ml.The missing print exceeds 50% of multiple characters.The missing print observed is rejectable per product specification.One syringe has slight contact smears to the right of the printed scale.The ink smears observed are acceptable per product specification printing and assembly records were reviewed as part of this device history record review.Print defects were found during the manufacture of this batch.Adjustments were made, including removing jammed part in dial, and product was requalified per applicable aql before production resumed.Batch 7313711 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Probable root cause.1.¿particulate¿ ¿ potential root cause for the loose foreign matter defect is associated with the material handling and assembly process.2.¿inclusions¿ ¿ potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded fm is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.3.¿damage¿ ¿ potential root cause for the damaged plunger rod and stopper angularity observed is associated with the assembly process.4.¿print¿ ¿ potential root cause for the print defects is associated with the printing process.Conclusion(s): 1.¿particulate¿ and ¿inclusions¿ ¿the defects observed in the samples received were considered cosmetic and acceptable per product specification.Furthermore, they occur at low occurrence levels and are typically well within the acceptable quality limits.No corrective actions are necessary at this time.No corrective actions are necessary at this time.1.¿damage¿ these defects typically occur at extremely low frequency during the high speed manufacturing process and are usually isolated incidents.Controls are in place to isolate and contain defects to ensure the quality of the final product.However, a few pieces with defects may escape detection.No corrective actions are necessary at this time.2.¿print¿ ¿ink spots outside the print area do not affect the volumetric accuracy nor functionality of the syringe, and are considered a cosmetic defect.Missing print defects are rare but may occur at low frequency during the high speed manufacturing process.Controls are in place that include periodic print quality checks and print pad changes to ensure consistent print quality.No corrective actions are necessary at this time.Controls are in place to ensure containment of defects and quality of the final product.They include periodic in-process inspections at various stages of manufacturing.The samples received should be representative of the overall defects reported by the customer (¿bd defects¿ pdf report).However, based on the evaluation performed, it appears there is a discrepancy in the acceptance criteria.Our recommendation is to reach out to the customer to align product acceptance criteria and customer expectations.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¿ SYRINGE
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7719943
• MDR Text Key: 115139579
• Report Number: 1213809-2018-00435
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 301073
• Device Lot Number: 7313711
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 07/02/2018
• Supplement Dates FDA Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other