MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL WWD; PISTON SYRINGE

Model Number	301997
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 2 syringe 10ml ll wwd experienced scale marking issues, broken/damaged plunger rods, and device damage/deformation while still considered operable.Product defects were noted prior to use.The following information was provided by the initial reporter: prior to use in the manufacturing, dented (damaged) barrels were found.
Event or Problem Description
It was reported that 2 syringe 10ml ll wwd experienced scale marking issues, broken/damaged plunger rods, and device damage/deformation while still considered operable.Product defects were noted prior to use.The following information was provided by the initial reporter: prior to use in the manufacturing, dented (damaged) barrels were found.
Additional Manufacturer Narrative
H.6.Investigation: multiple zip lock bags were received containing loose 10ml syringes along with a few pieces of top web from batch #8315843 (p/n 301997).The samples were visually evaluated.A bag marked 1664428 was identified.Two syringes with identical matching barrel damage as in bags from another complaint were observed.These damages range from scuffs to dents to severe deformations and cracks.These damages were aligned with cracked plunger rod ribs underneath those areas and scratched off scale markings.The majority of the damage appeared to be between 5ml marking and the flange.The potential root cause for the damaged barrels/plungers defect is associated with the assembly process.(b)(4).No corrective actions are necessary based on the defective rate identified.Batch 8315843 is considered in compliance with our product specification requirements.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Bag marked 1664431.Two (2) syringes were observed to have between one and three black foreign matter particles in the barrel wall outside scale markings at the 9ml level.At least one particle on each syringe was larger than level 3 in size, which is rejectable per product specification.The fm appeared to be embedded.Two (2) syringes were observed to have between one and three black foreign matter particles in their plunger rods.The particles were smaller than level 3 in size and acceptable per product specification.The barrels were identified to be from mold m-78 and plunger rods from mold m-79.Potential root cause for the embedded foreign matter defect is associated with the molding process.

• Brand Name: SYRINGE 10ML LL WWD
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10321898
• Report Number: 1213809-2020-00488
• Device Sequence Number: 825668
• Product Code: FMF
• UDI-Device Identifier: 30382903019978
• UDI-Public: 30382903019978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2023
• Device Model Number: 301997
• Device Catalogue Number: 301997
• Device Lot Number: 8315843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other