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

Model Number	309580
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 3086255, medical device expiration date: n/a, device manufacture date: 2013-04-24, medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.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 the expiration date was missing from the bd luer-lok¿ syringe with needle box before use.This occurred an unspecified number of times in lot 3086255 and an unspecified lot.The following information was provided by the initial reporter: "pharmacist has multiple boxes that do not have the expiration date on them so she would like to know what it is.".
Event or Problem Description
It was reported that the expiration date was missing from the bd luer-lok¿ syringe with needle box before use.This occurred an unspecified number of times in lot 3086255 and an unspecified lot.The following information was provided by the initial reporter: "pharmacist has multiple boxes that do not have the expiration date on them so she would like to know what it is.".
Additional Manufacturer Narrative
H.6.Investigation summary: multiple boxes were reported as not having the expiration date for material number 309580.Two lot numbers were reported, 3086255 and 2058082.No photos or samples were received for evaluation.The lot number 2058082 is invalid and could not be evaluated.Batch 3086255 was manufactured in 2013, prior to the udi requirements that mandated marking individual packaging with expiration date.This batch was manufactured correctly per product design at that time.Batch 3086255 expired 5 years after the date of manufacture.Based on the batch and product information provided no defect was identified.Dhr review: batch 3086255 was manufactured in 2013, prior to the udi requirements that mandated marking individual packaging with expiration date.This batch was manufactured correctly per product design at that time.Batch 3086255 expired 5 years after the date of manufacture.The dhr for batch 3086255 (309580) is no longer available for review as records are only retained for seven years.H3 other text : see h.10.

• Brand Name: BD LUER-LOK SYRINGE WITH NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10454585
• Report Number: 1213809-2020-00575
• Device Sequence Number: 11467235
• Product Code: FMF
• UDI-Device Identifier: 30382903095804
• UDI-Public: 30382903095804
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Pharmacist
• 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: Health Professional
• Device Model Number: 309580
• Device Catalogue Number: 309580
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 08/26/2020
• 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