MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Model Number	309571
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
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.
Event or Problem Description
It was reported that the bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle experienced foreign matter on device cannula.The following information was provided by the initial reporter: i opened a new syringe needle and noticed a hair or metal sliver on the end of the needle (it was hard to tell) i put the cap on, then removed the cap, pull the plunger back to get the liquid out of the needle, put the cap back on, replaced the needle.
Event or Problem Description
It was reported that the bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle experienced foreign matter on device cannula.The following information was provided by the initial reporter: i opened a new syringe needle and noticed a hair or metal sliver on the end of the needle (it was hard to tell) i put the cap on, then removed the cap, pull the plunger back to get the liquid out of the needle, put the cap back on, replaced the needle.
Additional Manufacturer Narrative
H.6.Investigation: two photos were received and evaluated.One photo showed a box label from batch #1090648.One photo showed a close-up of a syringe needle (p/n 309571), visible strands of foreign matter could be seen extending from the cannula.This foreign matter which appeared to be metal shavings and was non-conforming per product specification.Potential root cause for foreign matter defect is associated with the needle supplier¿s manufacturing process.The photos will be forwarded to the needle supplier for further evaluation and investigation.Further investigation was performed.Two photos were provided.One photo shows a case label.The other photo shows a needle assembly with no plastic shield.The needle has a string of foreign material towards the needle tip.From the photo there is no way to confirm the foreign matter material.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.

• Brand Name: BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12207230
• Report Number: 1213809-2021-00506
• Device Sequence Number: 12073256
• Product Code: FMF
• UDI-Device Identifier: 30382903095712
• UDI-Public: 30382903095712
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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: 03/31/2026
• Device Model Number: 309571
• Device Catalogue Number: 309571
• Device Lot Number: 1090648
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1