MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB; PISTON SYRINGE

Model Number	305924
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl sftygld 25x1 rb plunger detached.This was discovered during use.The following information was provided by the initial reporter: material no.305924 batch no.7093912.It was reported that the plunger detached from the black rubber.Per email from customer: plunger detached from the black rubber after drawing up vaccine.Plunger is loose and slides to end of syringe.This is the second one in a week but from a different box.No others identified in the box.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl sftygld 25x1 rb plunger detached.This was discovered during use.The following information was provided by the initial reporter: material no.305924 batch no.7093912.It was reported that the plunger detached from the black rubber.Per email from customer: plunger detached from the black rubber after drawing up vaccine.Plunger is loose and slides to end of syringe.This is the second one in a week but from a different box.No others identified in the box.
Additional Manufacturer Narrative
H.6.Investigation: two 3ml syringes with safetyglide needle assemblies attached in opened blister packs (p/n 305924) were received and evaluated.One blister pack was from batch 7093912 and one was from batch 7093907.It was observed in both syringes, the end of the plunger rods were broken off inside the stopper and were rejectable per product specification.Potential root cause for the broken plunger rod 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.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9425918
• Report Number: 1213809-2019-01226
• Device Sequence Number: 19517766
• Product Code: FMF
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/28/2020

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 305924
• Device Catalogue Number: 305924
• Device Lot Number: 7093912
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/29/2020
• 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