MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ POSIFLUSH HEPARIN SYRINGE; UNKNOWN

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problems Syncope (1610); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Reaction (2414)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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.The customer's address is unknown.(b)(6) has been used as a default.  a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the unspecified bd¿ posiflush heparin syringe product caused a reaction in the patient.The nurse was present during the time of event.The patient experienced heart complications, fainting, extreme blood pressure 64/40, low heart rate and excessive vomiting.Leakage occured at the pic-line site however, no reports of blood exposure occurred.No further information given at this time.

Manufacturer Narrative

Investigation summary: prior to the report of infection evaluated in (b)(4), there was no trend for infection or reaction cases reported for franklin product.This complaint is part of a new trend which began in april 2018, capa (b)(4) was initiated to address this issue.As no lot number was provided, a dhr review could not be completed.Samples and/or pictures were not provided for evaluation.Investigation conclusion: a review of all lot sterility testing performed for product released between april 2018 & may 2018 confirmed that no organism growth was identified for any lots released during the shelf life of this product.The root cause analysis of the reported infection/reaction cases under capa (b)(4) as not identified a direct causation between the infections and the bd franklin product.

Event Description

It was reported that the unspecified bd¿ posiflush heparin syringe product caused a reaction in the patient.The nurse was present during the time of event.The patient experienced heart complications, fainting, extreme blood pressure 64/40, low heart rate and excessive vomiting.Leakage occured at the pic-line site however, no reports of blood exposure occurred.No further information given at this time.

• Brand Name: UNSPECIFIED BD¿ POSIFLUSH HEPARIN SYRINGE
• Type of Device: UNKNOWN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7592161
• MDR Text Key: 110784553
• Report Number: 2243072-2018-00360
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other