MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problems Complete Blockage (1094); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

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 bd posiflush¿ normal saline syringe plunger was difficult to move and couldn't push out saline during use.The following information was provided by the initial reporter: "flush syringes will not dispense liquid.Can you please provide additional details in regards to the issue? could not push the saline out of the syringe.Was there any patient impact or patient involvement? no.Did you experience any adverse events as a result of this reported defect? no.

Event Description

It was reported that the bd posiflush¿ normal saline syringe plunger was difficult to move and couldn't push out saline during use.The following information was provided by the initial reporter: "flush syringes will not dispense liquid.Can you please provide additional details in regards to the issue? could not push the saline out of the syringe was there any patient impact or patient involvement? no.Did you experience any adverse events as a result of this reported defect? no".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 02-feb-2023.H6: investigation summary a device history record review was completed for provided material number 306546 and lot number 2263056.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one (1) physical sample was returned for evaluation by our quality engineer team.A silicone distribution test was performed on the sample.The test results showed a correct distribution of silicone for functionality of the product; therefore, the reported defect could not be confirmed.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16301658
• MDR Text Key: 308838768
• Report Number: 3002682307-2023-00011
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306546
• Device Lot Number: 2263056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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