MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL; PISTON SYRINGE

Catalog Number	305060
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe 3ml ll w/ndl 18x1-1/2 blunt fill had a scale marking issue.The following information was provided by the initial reporter: "we have found several syringes that were not stamped correctly during production.It appears they have all came from lot # 3173932.I have included a photo of the syringe missing all the lines and partial of the numbers and the front of a package with all the lot # and info needed.I currently have 14 they came from several different packaged boxes but all the same lot number so far.I know there were a few that were thrown away thinking it was a fluke issue until we discovered it was happening more." product: bf305060~tpmecc.Product name: syringe 3ml luer-lok w/blunt fill needle.
Event or Problem Description
Material#: 305060 lot#: 3173932.It was reported by the customer that the rcc received a complaint via email.Email(s) attached.We have found several syringes that were not stamped correctly during production.It appears they have all came from lot # 3173932.I have included a photo of the syringe missing all the lines and partial of the numbers and the front of a package with all the lot # and info needed.I currently have 14 they came from several different packaged boxes but all the same lot number so far.I know there were a few that were thrown away thinking it was a fluke issue until we discovered it was happening more.Product: bf305060~tpmecc, product name: syringe 3ml luer-lok w/blunt, fill needle.
Additional Manufacturer Narrative
Four photos of 3ml luer-lok syringes were received by bd.A quality engineer was able to examine the photos from batch 3173932 regarding item 305060.Two of the images are close-up images showing a sealed package from the top web view with applicable product information.Two other images each show a syringe in the sealed package with mostly missing print, however one shows the print from the zero line to the 2ml graduation line is grossly skewed.The condition observed is non-conforming per product specification.Potential root cause for the scale marking defects is associated with the marking process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.A device history record review was completed for provided lot number 3173932 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18587456
• Report Number: 1213809-2024-00034
• Device Sequence Number: 7140147
• Product Code: FMF
• UDI-Device Identifier: 30382903050605
• UDI-Public: (01)30382903050605
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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 Catalogue Number: 305060
• Device Lot Number: 3173932
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown