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

Catalog Number	305904
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device type: an additional product code applies as fmi.Pma/510(k)#: an additional pma/510(k)# applies to this device as k951254.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 6 syringes 3ml ll w/ndl sftygld 25x5/8 rb experienced a mix of product types in a pack.The following information was provided by the initial reporter: material no.: 305904 batch no.: 9255272.Needle was packaged as a 5/8" needle.This occurred in approx 6 out of 50 needles in the box.Can we please log this concern form in.It seems we are getting mfg and lot numbers with some needles that are incorrect.They are actually 1 inch when supposed to be 5/8th in.
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: 11/23/2020.H.6.Investigation: one sealed 3ml safetyglide combo package was received, confirmed to be from batch #9255272 (p/n 305904).The needle was taken out of the package and evaluated using the cannula length gauge.The needle cannula length was confirmed to be 1¿.This is incorrect for this product 305904, which is 5/8¿.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.Corrective and preventative action, capa#79055, was opened to investigate dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.
Event or Problem Description
It was reported that 6 syringes 3ml ll w/ndl sftygld 25x5/8 rb experienced a mix of product types in a pack.The following information was provided by the initial reporter: material no.: 305904 batch no.: 9255272 needle was packaged as a 5/8" needle.This occurred in approx 6 out of 50 needles in the box.Can we please log this concern form in.It seems we are getting mfg and lot numbers with some needles that are incorrect.They are actually 1 inch when supposed to be 5/8th in.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
• Common Device Name: PISTON SYRINGE, HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10929623
• Report Number: 1213809-2020-00849
• Device Sequence Number: 2478227
• Product Code: FMF
• UDI-Device Identifier: 00382903059041
• UDI-Public: 00382903059041
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/08/2020

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 Catalogue Number: 305904
• Device Lot Number: 9255272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1