MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL SFTYGLD 22X1-1/2 RB; PISTON SYRINGE

Model Number	305906
Medical Device Problem Codes	Retraction Problem (1536); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2020
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 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 22x1-1/2 rb needle was missing safety shield in package.This was discovered before use.The following information was provided by the initial reporter: material no.: 305906 batch no.: 9270294.It was reported that the package contained a needle that was missing safety shield.
Additional Manufacturer Narrative
H.6.Investigation summary: four photos were received and evaluated.The photos depicted a single sealed safetyglide 3ml combo package, confirmed to be from batch #9270294 (p/n 305906) cav 19.The package was observed to have 3ml syringe and shielded needle together in the same syringe cavity of the bottom web, while a second unshielded needle was present in the needle cavity of the bottom web.This is rejectable condition per product specification.A potential root cause for the extra unshielded needle is associated with the packaging process.Corrective actions were taken to address this defect.Additional guards were installed around needle material handling system in the packaging machine to prevent occasional extra needles from falling into cavities during the packaging process.Completed: 21 apr 2020.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trend.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl sftygld 22x1-1/2 rb needle was missing safety shield in package.This was discovered before use.The following information was provided by the initial reporter: material no.: 305906 batch no.: 9270294 it was reported that the package contained a needle that was missing safety shield.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 22X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10107364
• Report Number: 1213809-2020-00352
• Device Sequence Number: 3467876
• Product Code: FMF
• UDI-Device Identifier: 30382903059066
• UDI-Public: 30382903059066
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/19/2020

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: 08/31/2024
• Device Model Number: 305906
• Device Catalogue Number: 305906
• Device Lot Number: 9270294
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 06/19/2020
• 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