MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number 306546

Device Problems Material Separation (1562); Failure to Deliver (2338)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: it was reported that the plunger stops at 5ml mark, and the rubber stopper is coming loose once the plunger is forced passed the 5ml mark.To aid in the investigation, one empty sample with no packaging flow wrap was received for evaluation by or quality team.A visual inspection was performed and no defects or imperfections were observed.The 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 the result was within specification.It could be possible that 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.A device history record review was completed for provided material number 306546, lot number 1116325.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.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 returned sample analysis the symptom reported by the customer of plunger movement difficult is confirmed.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 10 ml bd posiflush¿ normal saline syringe experienced difficult plunger movement, and stopper separation from plunger.The following information was provided by the initial reporter: flush plunger stops at 5ml mark.The rubber stopper is coming loose off the plastic plunger inside syringe once you force the plunger past the 5ml marker.

• Brand Name: 10 ML BD POSIFLUSH NORMAL 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12186060
• MDR Text Key: 262194314
• Report Number: 1911916-2021-00698
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 1116325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• 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