MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE BLUNT FILL 5ML LL W/NDL 18X1-1/2; PISTON SYRINGE

Model Number	305062
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0199226, medical device expiration date: 2025-06-30, device manufacture date: 2020-07-17.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe blunt fill 5ml ll w/ndl 18x1-1/2 stopper was damaged and another syringe leaked.The following information was provided by the initial reporter: material no.305062, batch no.0199226, unknown.It was reported that stopper looks melted inside one syringe and another syringe had medication that leaked behind stopper.
Additional Manufacturer Narrative
H.6.Investigation: one 5ml syringe with needle attached in an opened blister pack from batch 0199226 (p/n 305062) was received and evaluated.The syringe appeared to be manipulated as clear fluid droplets were present inside and outside the fluid path.It was observed there was damage present at the bottom of the barrel with deformations present between the zero line and 1ml marking, which was rejectable per product specification.Potential root cause for the damaged barrel defect is associated with the assembly process.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.
Event or Problem Description
It was reported that syringe blunt fill 5ml ll w/ndl 18x1-1/2 stopper was damaged and another syringe leaked.The following information was provided by the initial reporter: material no.305062 batch no.0199226, unknown.It was reported that stopper looks melted inside one syringe and another syringe had medication that leaked behind stopper.

• Brand Name: SYRINGE BLUNT FILL 5ML LL W/NDL 18X1-1/2
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10837764
• Report Number: 1213809-2020-00795
• Device Sequence Number: 3216597
• Product Code: FMF
• UDI-Device Identifier: 30382903050629
• UDI-Public: 30382903050629
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: Health Professional
• Device Model Number: 305062
• Device Catalogue Number: 305062
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1