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

Model Number	301997
Medical Device Problem Codes	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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8315843.Medical device expiration date: 2023-11-30.Device manufacture date: 2018-11-11.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that 20 syringe 10ml ll wwd experienced a failure to contain blood/medication, broken/damaged plunger rods, and scale marking issues.Product defect were noted prior to use.The following information was provided by the initial reporter: prior to use in the manufacturing process, cracked (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 (b)(6)).The samples were visually evaluated.Nineteen syringes were observed to have barrel damage, ranging from scuffs to dents to severe deformations and cracks.This damage was aligned with cracked plunger rod ribs underneath those areas and scratched off scale markings.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.The aql for incorrect assembly is 0.65%.The defective rate identified is 21 out of 333,200, which is 0.0063%.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.
Event or Problem Description
It was reported that 20 syringe 10ml ll wwd experienced a failure to contain blood/medication, broken/damaged plunger rods, and scale marking issues.Product defect were noted prior to use.The following information was provided by the initial reporter: prior to use in the manufacturing process, cracked (damaged) barrels were found.

• 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: 10317914
• Report Number: 1213809-2020-00485
• Device Sequence Number: 19038947
• 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 Model Number: 301997
• Device Catalogue Number: 301997
• Device Lot Number: SEE H10
• 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: 07/23/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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