MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Model Number	309578
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.The customer's address is unknown:  (b)(6), usa has been used as a default.  device manufacture date: unknown.(b)(4).Investigation summary: no photos or samples were received for evaluation.Since no samples displaying the reported condition were received a potential root cause could not be defined and no corrective actions are necessary at this time.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.
Event or Problem Description
It was reported that an unspecified number of bd 3ml syringe luer-lok¿ tips with bd precision glide¿ needles experienced missing label information which was noted prior to use.The following information was provided by the initial reporter: material no: 309578 batch no: unknown.Caller asking for expiration date/shelf life for syringe# 309578.Caller states there are no markings on the syringe package.Asked caller if there is a date or hourglass marking on package.The shelf life for all bd syringes is 5 years from date of manufacture.Some bd products do not have an expiration date on the packaging.The fda does not require dating on all products.We cannot recommend using products past expiration dates.Offered caller to send me picture of packaging and caller declined.Asked caller if she has additional product numbers and she confirms she has six boxes of syringes with different product numbers.Asked caller to send email to medical.Support@bd.Com and list the product numbers and if there are any markings or dates on the packaging and we will assist her.Caller declined and states she will call customer service again as she does not need that detailed of information.

• Brand Name: BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10134184
• Report Number: 1213809-2020-00381
• Device Sequence Number: 11306910
• Product Code: FMF
• UDI-Device Identifier: 30382903095781
• UDI-Public: 30382903095781
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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 Model Number: 309578
• Device Catalogue Number: 309578
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/09/2020
• 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