MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T W/NDL SFTYGLD 27X5/8 RB; PISTON SYRINGE

Model Number	305927
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a stopper issue occurred before use with a syringe 1ml s/t w/ndl sftygld 27x5/8 rb.The following information was provided by the initial reporter, "double of stopper." 2 occurrences were reported.
Additional Manufacturer Narrative
H.6.Investigation summary: one photo and one 1ml syringe with safetyglide needle assembly in an opened blister pack from batch 7310585 (p/n 305927) was received and evaluated.It was observed there was an extra stopper inside the syringe a criteria of rejection per product specification.Potential root cause for the extra stopper defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.Batch 7310585 is considered in compliance with our product specification requirements.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.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 trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that a stopper issue occurred before use with a syringe 1ml s/t w/ndl sftygld 27x5/8 rb.The following information was provided by the initial reporter, "double of stopper." 2 occurrences were reported.

• Brand Name: SYRINGE 1ML S/T W/NDL SFTYGLD 27X5/8 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9548970
• Report Number: 1213809-2019-01332
• Device Sequence Number: 3392898
• Product Code: FMF
• UDI-Device Identifier: 30382903059271
• UDI-Public: 30382903059271
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980580
• 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): 01/17/2020

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: 10/31/2022
• Device Model Number: 305927
• Device Catalogue Number: 305927
• Device Lot Number: 7310585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/17/2020
• 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