MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Model Number 305269

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/13/2020

Event Type  Injury  

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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not necessary at this time.

Event Description

It was reported that the bd integra¿ syringe with detachable needle made a "pop noise" during use and remained in the injection site.The consumer was taken to the er, where an x-ray was completed.A surgeon was visited on (b)(6) 2020, where a "fluoroscope" was done, and a "post operation clip from another incident non related to bd" was found.The following information was provided by the initial reporter: "parent reported mom gave injection to son thought needle broke off in site.Mom heard a pop noise when completed the injection and needle was still in son's site.Mom took her son to the er and they completed an xray.They then went to see a surgeon (b)(6) 2020 they completed a fluoroscope and found a post operation clip from another incident non related to bd.Mom calling bd asking of the retracting tech of the integra syringe and wants to find the needle within the syringe.".

• Brand Name: BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9787278
• MDR Text Key: 184161015
• Report Number: 1213809-2020-00160
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052692
• UDI-Public: 30382903052692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 305269
• Device Catalogue Number: 305269
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention