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

Catalog Number	309581
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that 2 of the bd luer-lok¿ syringe with attached needle were unable to draw medication, only a few drops.The following information was provided by the initial reporter: spouse called for assistance with drawing his wife's b-12.Two attempts were made to draw medication, but it was unsuccessful.Stated, only a few drops went into syringes stated, he tried the syringe on two different vials, but the result was the same spouse stated, he tried a few times with the same two syringes before calling in.
Additional Manufacturer Narrative
Investigation summary: it was reported the needle would not draw up medication.As a sample was not returned, a thorough sample investigation could not be completed.Previous investigations have revealed that process variations during the needle lubricant application can create clogged needles.Several quality initiatives have been implemented on our manufacturing line to ensure that the needle lubricant application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the needle lubricant is applied uniformly to the needle.A device history record review was completed for provided material number 309581, lot number 1256759.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 1256759 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.To date, there have been no other similar events reported for this lot.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.(b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 1256759 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE
• 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: 16000649
• Report Number: 1213809-2022-01267
• Device Sequence Number: 6655877
• Product Code: FMF
• UDI-Device Identifier: 50382903095815
• UDI-Public: 00382903095810
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2022

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: Lay User/Patient
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 309581
• Device Lot Number: 1256759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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