MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD POSIFLUSH¿ DEVICE; FLUSH SYRINGE

Catalog Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045)

Event Date 11/18/2013

Event Type  Death  

Manufacturer Narrative

There are multiple bd locations where this device may have been manufactured.A catalog and lot number were not provided when bd was made aware of 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 of this mdr and the (b)(4) fda registration number has been used for the manufacture report number.Date of death: on or about (b)(6) 2013.Date of event: on or about (b)(6) 2013.Medical device expiration date: unknown.Device manufacture date: unknown.Results: a sample is not available for evaluation.A review of the device history record could not be performed as a lot number for this incident was not provided.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.Sample is not available for evaluation.

Event Description

It was reported that an unspecified bd posiflus device was associated with a patient death.It was alleged that a patient died in the hospital after being administered with numerous drugs and iv solutions which led to an "acute vascular response in her lungs which lead to low blood pressure and respiratory distress leading to her death." he patient was treated at (b)(6) on or about (b)(6) 2013.

• Brand Name: UNSPECIFIED BD POSIFLUSH¿ DEVICE
• Type of Device: FLUSH 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: 5287731
• MDR Text Key: 33228701
• Report Number: 2243072-2015-000165
• Device Sequence Number: 1
• Product Code: NGT
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death