MAUDE Adverse Event Report: BD BD POSIFLUSH NORMAL SALINE FILLED SYRINGE; FLUSH SYRINGE

Catalog Number 306546

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Reaction (2414); Increased Respiratory Rate (2486)

Event Date 01/08/2015

Event Type  Injury  

Event Description

It was reported that after using a bd posiflush normal saline filled syringe to flush the pt's port, the pt had a reaction which resulted in an increased heart rate, low blood pressure, and increased respirations.She was them admitted to the hospital.While in the hospital the pt's port was flushed with a manually filled bd hypodermic syringe from a saline bag and she did not have the same reaction.Of note, the pt reported that she had previously had similar reactions when a flush syringe was used to access her port.In addition, her port was replaced in (b)(6) 2014 after having had a similar reaction.

Manufacturer Narrative

Results: a sample was not returned for eval.A review of the device history records revealed no irregularities during the mfr of reported lot number 4301973.Conclusions: without a sample an absolute root cause for this incident could not be identified.If additional info is received regarding the incident, a supplemental report will be submitted.(b)(4).

• Brand Name: BD POSIFLUSH NORMAL SALINE FILLED SYRINGE
• Type of Device: FLUSH SYRINGE
• Manufacturer (Section D): BD; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: aaron larson ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652406
• MDR Report Key: 4452595
• MDR Text Key: 5423910
• Report Number: 2243072-2015-00011
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 306546
• Device Lot Number: 4301973
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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): Hospitalization; Required Intervention