MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problems Burst Container or Vessel (1074); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.No lot # provided.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 during use, an unspecified bd syringe, cracked and exploded the medication (xolair) while being injected.This occurred on two separate occasions.There was no report of injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Since no samples displaying the condition reported are available for examination, bd was unable to fully investigate this incident.No root cause can be determined as no samples were received.Examination of the product involved may provide clarification as to the cause for the reported failure.Based on no sample, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failures.Investigation conclusion: no root cause can be determined as no samples were received.

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7176514
• MDR Text Key: 96837255
• Report Number: 2243072-2017-00432
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• 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): Other