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

Model Number	305904
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
" medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.".
Event or Problem Description
It was reported that a syringe 3ml ll w/ndl sftygld 25x5/8 rb had a loose needle during use.The following was reported by the initial reporter: "while using a safetyglide syringe (3ml 25g x 5/8) the needle popped off of the plastic holder as i was taking the needle out of a vaccine vial.The needle itself appeared intact and undamaged with a bead of glue (?) on the side of the needle.No vaccine was lost, no patient or staff were affected.This needle/syringe attachment was defective.".

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11857960
• Report Number: 1213809-2021-00353
• Device Sequence Number: 14457117
• Product Code: MEG
• UDI-Device Identifier: 30382903059042
• UDI-Public: 30382903059042
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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: Health Professional
• Device Model Number: 305904
• Device Catalogue Number: 305904
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1