MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB; PISTON SYRINGE

Model Number	305905
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: 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 3ml ll w/ndl sftygld 23x1 rb had a defective stopper.The following information was provided by the initial reporter, "the black rubber plug of the syringe plunger is deformed.".
Event or Problem Description
It was reported that syringe 3ml ll w/ndl sftygld 23x1 rb had a deffective stopper.The following information was provided by the initial reporter: "the black rubber plug of the syringe plunger is deformed.".
Additional Manufacturer Narrative
H6: investigation summary: one photo of the top view of a blister pack from batch 9304558 (p/n 305905) was received and evaluated.No defects could be confirmed from the photo.The reported defect could not be confirmed from the photo received.Additional photos of the defect are necessary for evaluation.Furthermore, 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.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10759480
• Report Number: 1213809-2020-00763
• Device Sequence Number: 3266814
• Product Code: FMF
• UDI-Device Identifier: 30382903059059
• UDI-Public: 30382903059059
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 09/30/2024
• Device Model Number: 305905
• Device Catalogue Number: 305905
• Device Lot Number: 9304558
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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