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

Model Number	309572
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/12/2020
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 expiration date: 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 the box of bd syringes with luer-lok¿ tip and bd precisionglide¿ needle had no expiration date on it before use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "pharmacist called to inquire about expiration and disposal of expired syringes.Lot #s 3298116, 4154804, 0054508, 2150297 and 3212011.Pharmacist said there is no expiration date on the boxes.".
Event or Problem Description
It was reported that the box of bd syringes with luer-lok¿ tip and bd precisionglide¿ needle had no expiration date on it before use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "pharmacist called to inquire about expiration and disposal of expired syringes.Lot #s 3298116, 4154804, 0054508, 2150297 and 3212011.Pharmacist said there is no expiration date on the boxes.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received for evaluation.The batch numbers provided: 4154804, 3298116, 0054508, 2150297, and 3212011 were all manufactured prior to the udi requirements that mandated marking individual packaging with expiration date.These batches were all manufactured correctly per product design at that time.The most recent batch, #4154804, was expired as of 31 may 2019.The reported defect was not identified based on the product information provided and no corrective actions are necessary at this time.The dhr is no longer available for following batch and product numbers as records are only retained for seven years.H3 other text : see h.10.

• Brand Name: BD 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: 10112264
• Report Number: 1213809-2020-00358
• Device Sequence Number: 14054808
• Product Code: FMF
• UDI-Device Identifier: 30382903095729
• UDI-Public: 30382903095729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/04/2020

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: 309572
• Device Catalogue Number: 309572
• Device Lot Number: 3298116
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/04/2020
• 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