MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED HYPO-POSIFLUSH PRE-FILLED SYRINGE

Catalog Number UNKNOWN

Device Problem Short Fill (1575)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2019

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: 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.Medical device expiration date: unknown.Initial reporter phone #: unknown.Device manufacture date: unknown.Investigation summary: one photo was provided.The rubber stopper is at 5ml-6ml mark therefore failure mode is verified.Root cause for the reported failure mode is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history review could not be completed as no batch number was provided.Root cause description: root cause for the reported failure mode is undetermined.

Event Description

It was reported there was insufficient saline with a unspecified hypo-posiflush pre-filled syringe.The following information was provided by the initial reporter, translated from (b)(6) to english: before the infusion, the infusion line was cleaned to prevent blood blockage it was found that the pre-filled saline in flush was insufficient, delaying the patient's time for cleaning, and the patient was immediately replaced with a new flush.

• Brand Name: UNSPECIFIED HYPO-POSIFLUSH PRE-FILLED SYRINGE
• Type of Device: FLUSH
• 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 ; 8015652341
• MDR Report Key: 8566797
• MDR Text Key: 143666328
• Report Number: 2243072-2019-00821
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem 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?: Yes
• Date Manufacturer Received: 04/15/2019
• 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): Other