MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Model Number	305903
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: hypodermic single lumen needle.Medical device type: fmi.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980580 (syringe), pma / 510(k)#: k951254 (needle).(b)(4).Investigation summary: two photos and one opened 1ml safetyglide combo package were received, confirmed to be from batch #0140992 by our quality team.The sample was visually evaluated.The package contained a shielded sg needle and a 1ml s/t syringe.The syringe was observed to have multiple brown foreign matter particles embedded in the barrel, with majority around the tip, but some also found in the wall.Many particles were larger than level 3 in size, which is rejectable per product specification.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the investigation, the potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded fm is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.Per procedure, after start up, all molded parts are scrapped until no degraded plastic is observed.If this is not performed thoroughly a piece with this condition can get through.This type of defect is cosmetic and does not pose risk to the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: confirmed: bd was able to duplicate or confirm the customer's indicated failure mode with the sample and photos provided.Root cause description: potential root cause for the embedded foreign matter defect is associated with the molding process.Rationale: the aql for embedded foreign matter is 0.65%.The defective rate identified is (b)(4).No corrective actions are necessary based on the defective rate identified.Batch 0140992 is considered in compliance with our product specification requirements.
Event or Problem Description
It was reported that brown foreign matter was found in the bd safetyglide¿ insulin syringe with attached needle packaging before use.The following information was provided by the initial reporter: i have a weird situation with a syringe.One of the techs opened an 1ml syringe/safety needle package and the syringe is contaminated with a brown substance in it.The tech said the package was closed and noticed the dirty syringe while opening it for a sterile tray.

• Brand Name: BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10715224
• Report Number: 1213809-2020-00732
• Device Sequence Number: 3358712
• Product Code: FMF
• UDI-Device Identifier: 30382903059035
• UDI-Public: 30382903059035
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2020

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: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 305903
• Device Catalogue Number: 305903
• Device Lot Number: 0140992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/21/2020
• 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