MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL PRE-FILLED SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Model Number 306546

Device Problem Mechanical Jam (2983)

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

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: exec summary: no physical device samples were returned.The investigation was performed based primarily on the image(s) provided.It was reported the plunger is sticking.To aid in the investigation, two disassembled empty samples with no packaging blister or tip cap were received for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.Each sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and all results were within specification.It could be possible the customer is getting some products that are towards the high specification limit and are related to the symptom reported by the customer since they require extra force than normal to expel the solution.Previous investigations have revealed that improper silicone application within the syringe barrel can create plunger resistance.Several quality initiatives have been implemented on our manufacturing line to ensure that the silicone application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the silicone is uniformly applied to the syringe barrel.Based on the investigation and with the sample analysis the symptom reported by the customer could not be confirmed and the root cause could not be determined.A review of the complaint lot history check was performed and this is the 4th related complaint for plunger movement difficult on lot # 2021612.No non-conformance's were raised in association with this type of event for this lot, concluding all inspections were performed as per the applicable operations and met qc specifications.Capa/sa: based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time.Dhr review: a lot history review for batch 2021612 was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.

Event Description

It was reported that 1 bd posiflush¿ normal pre-filled saline syringe had plunger movement issues.The following information was provided by the initial reporter : the customer reported that the plungers are stopping at the same point.

• Brand Name: BD POSIFLUSH¿ NORMAL PRE-FILLED SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14598596
• MDR Text Key: 294522078
• Report Number: 1911916-2022-00287
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• 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
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 306546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• 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