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

Model Number	309571
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device lot #: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 3 bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needles experienced missing label information and incorrect label information.Product defects were noted prior to use.The following information was provided by the initial reporter: material no: 309571, batch no: 5244859.Pharmacy and does not have any retail.Pharmacy tech noticed the bottom has an expiration date that does not match the expiration date given to her by a bd rep when she called the customer service line.Missing the "exp " on the bottom of the box but there is a date but is assuming this is the expiration date.Issue is with 3 boxes of 100 per box.
Additional Manufacturer Narrative
H.6.Investigation: three photos were received and evaluated.The photos depicted four boxes of 3ml syringes with labels from batch #5244859 (p/n (b)(6)), as well as two blister packs with top web showing the same product but no batch #.The printed date on one side of all four boxes was (b)(6) 2005.Dhr review is not possible for batch manufactured in 2005.No records remain of this batch.Based on the labels provided, the label drawing was active in 2004 and 2005 only.Therefore, it batch #5244859 was manufactured in 2005, likely around the date printed on the box ¿(b)(6)2005¿ indicating (b)(6)2005.This batch of product has expired in 2010.At the time this batch was manufactured there were no requirements to have batch and expiration date printed on individual packaging.Present day 3ml product 309571 is batch and expiration dated as per regulatory requirement.Batch #5244859 has expired in year 2010.No defects confirmed.
Event or Problem Description
It was reported that 3 bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needles experienced missing label information and incorrect label information.Product defects were noted prior to use.The following information was provided by the initial reporter: material no: (b)(6) batch no: 5244859.Pharmacy and does not have any retail.Pharmacy tech noticed the bottom has an expiration date that does not match the expiration date given to her by a bd rep when she called the customer service line.Missing the "exp " on the bottom of the box but there is a date but is assuming this is the expiration date.Issue is with 3 boxes of 100 per box.

• 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: 10578296
• Report Number: 1213809-2020-00655
• Device Sequence Number: 3885573
• Product Code: FMF
• UDI-Device Identifier: 30382903095712
• UDI-Public: 30382903095712
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/29/2020

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: 309571
• Device Catalogue Number: 309571
• Device Lot Number: 5244859
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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