MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB; PISTON SYRINGE

Model Number	305904
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an unspecified number of syringe 3ml ll w/ndl sftygld 25x5/8 rb experienced a mix of product types in a pack and incorrect label information, which was noted prior to use.The following information was provided by the initial reporter: material no: 305904; batch no: 9255272.Customer called to report that they received a shipment and believe the labeling is incorrect.She ordered bd syringe safety guide, but believed she received another product.
Event or Problem Description
It was reported that an unspecified number of syringe 3ml ll w/ndl sftygld 25x5/8 rb experienced a mix of product types in a pack and incorrect label information which was noted prior to use.The following information was provided by the initial reporter: material no: 305904.Batch no: 9255272.Customer called to report that they received a shipment and believe the labeling is incorrect.She ordered bd syringe safety guide but believed she received another product.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 9/29/2020.H.6.Investigation: an opened shelf carton was returned, confirmed to be from batch #9255272 ¿ 3ml safetyglide combo 25 g x 5/8¿ product.The carton contained 45 sealed packaged sg combo syringes with needles, confirmed to be labeled with batch #9255272.The samples were visually evaluated.4 packages were confirmed to have the correct 25g x 5/8¿ needle.41 packages were confirmed to have incorrect 25g x 1¿ needle.A probable root causes is line clearance not performed properly, leaving 1¿ needles from previous batch at the machine that ended up being introduced into the complaint batch.Additional procedure clarification will be made to the line clearance form to address ambiguity identified with verifying needle bag clearance.Capa#79055 was initiated.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10638655
• Report Number: 1213809-2020-00694
• Device Sequence Number: 3094628
• Product Code: FMF
• UDI-Device Identifier: 30382903059042
• UDI-Public: (01)30382903059042
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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 Expiration Date: 08/31/2024
• Device Model Number: 305904
• Device Catalogue Number: 305904
• Device Lot Number: 9255272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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