MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE WITH NEEDLE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.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 that the needle tip of the unspecified bd¿ syringe with needle broke off inside the patient and made the medication dose unusable.The patient reportedly went to urgent care, but no other details were provided.The following information was provided by the initial reporter: a report was received on (b)(6) 2019 via ds.Pharmacist reported that a patient reported that the tip of needle broke off - early (b)(6) - dose unusable.Had to next dose - she did not call in - went to urgent care.No other details provided".

Event Description

It was reported that the needle tip of the unspecified bd¿ syringe with needle broke off inside the patient and made the medication dose unusable.The patient reportedly went to urgent care, but no other details were provided.The following information was provided by the initial reporter: a report was received on 15 mar 2019 via ds.Pharmacist reported that a patient reported that the tip of needle broke off - early march - dose unusable.Had to next dose - she did not call in - went to urgent care.No other details provided.".

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.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

• Brand Name: UNSPECIFIED BD SYRINGE WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8555644
• MDR Text Key: 143259376
• Report Number: 2243072-2019-00795
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention