MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS 10ML PRE-FILLED FLUSH SYRINGE NACL 0.9%

Catalog Number 306572

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908)

Event Date 09/18/2017

Event Type  Injury  

Manufacturer Narrative

Investigation: a sample is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Without a sample, an absolute root cause for this incident cannot be determined.(b)(4).

Event Description

It was reported that the patient developed an allergic reaction after the iv line was flushed with a bd posiflush¿ xs 10 ml pre-filled flush syringe nacl 0.9%.The patient was at the hospital to receive a scheduled iron infusion when, after the flush, her blood pressure increased and she developed symptoms consistent with a reaction.The infusion was stopped, patient was given epinephrine and about 20 minutes later the symptoms were gone and the patient was able to continue with her iron infusion.No further medical treatment was needed.

• Brand Name: BD POSIFLUSH¿ XS 10ML PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6942212
• MDR Text Key: 89255933
• Report Number: 9616657-2017-00013
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/05/2017

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: Other Health Care Professional
• Device Catalogue Number: 306572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/11/2017
• 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): Required Intervention