MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL EURO 125 S/C; PISTON SYRINGE

Model Number 309649

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

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 an unspecified number of syringes 5ml ll euro 125 s/c experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: in this batch 7/60 pieces sample printing ink around the syringe.

Manufacturer Narrative

H.6 investigation summary: eight loose 5ml syringes in opened packages were received.The samples arrived divided among 4 plastic bags.All packages were from batch #9290463 (p/n 309649).The samples were visually evaluated.7 of the syringes were observed to have numerous small ink smears on the barrel between 3ml and the ¿ml¿ markings.The ink spots were observed to be both in and outside the scale markings and circumscribed the entire barrel in that area.There were over 30 tiny ink spots on each barrel, primarily level 1 in size, with a few level 2 spots.The condition observed is rejectable per product specification.1 syringe was observed to have only two ink smears outside the scale markings ¿ level 1 and level 3 in size.This condition is acceptable per product specification.Ink smears as the ones observed in the samples received are a cosmetic defect and do not interfere with the product¿s fit, form, or function.Potential root cause for the ink smears defect is associated with the marking process.No corrective actions are necessary based on the defective rate identified.Batch 9290463 is considered in compliance with our product specification requirements.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.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 9290463 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.H3 other text : see h.10.

Event Description

It was reported that an unspecified number of syringes 5ml ll euro 125 s/c experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: in this batch 7/60 pieces sample printing ink around the syringe.

• Brand Name: SYRINGE 5ML LL EURO 125 S/C
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9505835
• MDR Text Key: 193632347
• Report Number: 1213809-2019-01292
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096498
• UDI-Public: 30382903096498
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 01/24/2020

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 Model Number: 309649
• Device Catalogue Number: 309649
• Device Lot Number: 9290463
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other