MAUDE Adverse Event Report: BECTON DICKINSON BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306573

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2021

Event Type  malfunction  

Event Description

It was reported that plunger movement difficulty occurred while using bd posiflush¿ pre-filled saline syringe.This occurred at least 3 times, however, no patient impact reported.The following information was provided by the initial reporter: third bd posiflush sp syriinge found in last week where the plunger would not move despite pressure placed on it.Syringe with each incident had been attached to the end of an iv start tubing used to flush iv once start has occurred to assess for position and blood return.Each time assistance was required from another staff member to replace syringe, each time noting that it was the plunger vs incorrect connection between tubings.First two incidents had not been reported - both assumed as operator" issue and syringes had been accidently discarded.

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A 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.Device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that plunger movement difficulty occurred while using bd posiflush¿ pre-filled saline syringe.This occurred at least 3 times, however, no patient impact reported.The following information was provided by the initial reporter: third bd posiflush sp syriinge found in last week where the plunger would not move despite pressure placed on it.Syringe with each incident had been attached to the end of an iv start tubing used to flush iv once start has occurred to assess for position and blood return.Each time assistance was required from another staff member to replace syringe, each time noting that it was the plunger vs incorrect connection between tubings.First two incidents had not been reported - both assumed as operator" issue and syringes had been accidently discarded.

• Brand Name: BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15523827
• MDR Text Key: 306503271
• Report Number: 2243072-2022-01708
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306573
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• 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