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	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
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.(b)(4).
Event or Problem Description
It was reported that syringe 3ml ll w/ndl sftygld 23x1 rb had a safety mechanism failure.This was discovered before use.The following information was provided by the initial reporter: safety mechanism can not work well.
Additional Manufacturer Narrative
D.10 device available for eval yes, d.10 returned to manufacturer on: 2020-08-17.H.6.Investigation summary one photo and one 3ml safetyglide combo in an opened blister from batch 9287062 (p/n 305905) was received and evaluated.It was observed the ribs of the hub were damaged with small plastic fragments protruding outwards and the safety mechanism was disconnected, which was rejectable per product specification.Potential root cause for the broken safety mechanism defect is associated with the needle manufacturing process.The samples will be forwarded to the needle manufacturing site for evaluation and potential root cause determination.Bd columbus was able to identify the root cause for the defect occurred on the safetyglide assembly line.The plastic hub is placed under the cannulator then the needle is positioned and assembled to the plastic hub adding the epoxy to fix it; after that, a plastic safety mechanism is assembled, then at the end the plastic shield is assembled to the part.In this case, the needle assembly mechanism was not properly assembled to the safety mechanism inducing the symptom reported.Based on the investigation and the analysis of the sample the symptom reported by the customer is verified.No corrective actions are required at this time.Bd will continue to monitor this lot and failure mode through monthly trending meetings.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl sftygld 23x1 rb had a safety mechanism failure.This was discovered before use.The following information was provided by the initial reporter: safety mechanism can not work well.

• 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: 10411632
• Report Number: 1213809-2020-00531
• Device Sequence Number: 16878731
• 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): 09/18/2020

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: 9287062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/18/2020
• 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