MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE W/ATTACHED BD¿ BLUNT FILL NEEDLE 18 G X 1 1/2 IN., 5 ML; PISTON SYRINGE

Model Number	305062
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to using a bd luer-lok¿ syringe with attached bd¿ blunt fill needle 18 g x 1 1/2 in., sterile single use, not for skin injection, 5 ml, the scale markings were missing.The following information was provided by the initial reporter: the syringe didn t have ml markings.
Additional Manufacturer Narrative
Date of event: the date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 21-apr-2022.Investigation: one loose 5ml syringe with needle (p/n 305062) was received.Through visual inspection, it is observed that the printed scale was entirely missing from the syringe.Additionally, some scuffing observed on various parts of the barrel, flange and collar.Since the syringe appears to have been extensively handled it is unclear where the scuffing occurred.The observed scale marking condition was non-conforming per product specification.Potential root cause for the scale missing defect is associated with the marking process.It is likely a clogged ink manifold due to improper ink viscosity maintenance led to the observed condition.Since the batch number is unknown a defective rate cannot be identified and corrective actions are not required.
Event or Problem Description
It was reported that prior to using a bd luer-lok¿ syringe with attached bd¿ blunt fill needle 18 g x 1 1/2 in., sterile single use, not for skin injection, 5 ml, the scale markings were missing.The following information was provided by the initial reporter: the syringe didn¿t have ml markings.

• Brand Name: BD LUER-LOK¿ SYRINGE W/ATTACHED BD¿ BLUNT FILL NEEDLE 18 G X 1 1/2 IN., 5 ML
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14190691
• Report Number: 1213809-2022-00231
• Device Sequence Number: 4408338
• Product Code: FMF
• UDI-Device Identifier: 30382903050629
• UDI-Public: 30382903050629
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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: 305062
• Device Catalogue Number: 305062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown