MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE; PISTON SYRINGE

Catalog Number 309581

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported with the use of the bd syringe with bd precisionglide¿ needle there was an issue with needle broke off in patient during injection.X-ray performed and the needle was shown to still be in patient.

Manufacturer Narrative

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 Description

It was reported with the use of the bd syringe with bd precisionglide¿ needle there was an issue with needle broke off in patient during injection.X-ray performed and the needle was shown to still be in patient.

• Brand Name: BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8203405
• MDR Text Key: 131646103
• Report Number: 1213809-2018-00947
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095811
• UDI-Public: 30382903095811
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309581
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention