MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD WEISS EPIDURAL NEEDLE; ANESTHESIA SPINAL NEEDLE

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Exsanguination (1841); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 10/12/2016

Event Type  Death  

Manufacturer Narrative

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 (b)(6) has been listed and the (b)(6) fda registration number has been used for the manufacture report number.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 as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

The following information was received from the initial reporter: (b)(6) complaint number: (b)(4).An adverse event report was received, in which your bd weiss epidural needle was listed as a suspect device.Event description: during an epicardial vt ablation procedure the patient developed a pericardial effusion.After the epicardial puncture was performed the patient's blood pressure dropped.An ultrasound and x-ray confirmed the effusion.They were unable to stop the bleeding and after 1 hour the patient died.A bd weiss epidural needle was used to perform the epicardial puncture.Event date: (b)(6) 2016.Procedure: epicardial vt ablation.The initial reporter indicated that the incident occurred at the following location: (b)(6).This facility in (b)(6) was contacted by bd, including the facility's (b)(6) and (b)(6), and bd was advised that the reported death did not occur there.Contact was then made with the initial reporter to verify the facility information where the death occurred and she advised that no further information was available.There is no information regarding the specific bd device, such as a catalog and lot number, other than that an unspecified bd weiss epidural needle was used.Of note, the described use of the bd weiss epidural needle is an off labeled use and such use is not approved or encouraged by bd.

• Brand Name: UNSPECIFIED BD WEISS EPIDURAL NEEDLE
• Type of Device: ANESTHESIA SPINAL NEEDLE
• 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: 6083358
• MDR Text Key: 59328381
• Report Number: 2243072-2016-00040
• Device Sequence Number: 0
• Product Code: BSP
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/07/2016
• 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