MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGES,; SALINE, VASCULAR ACCESS FLUSH

Model Number 306546

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

It was reported while using bd posiflush¿ normal saline syringes, the plunger movement was difficult.There was no report of patient impact.Patient 2 of 3.The following information was provided by the initial reporter: detail: the 10ml saline syringe will not completely empty.It was reported they stop around the 1ml mark on the syringe and no amount of force will advance the syringe.The current sample was pushed so hard than you can no longer withdraw the syringe back.This has happened 3 times this morning.One patient didn't get the entire medication, and another got an iv replaced that did not need to occur.

Manufacturer Narrative

Investigation summary it was reported the syringe will not completely empty, and no amount of force will advance it.To aid the investigation, one empty sample with no packaging flow wrap, or tip cap, was received for evaluation by our 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.A device history record review was completed for provided material number 306546, lot number 2179528.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed, and a probable root cause could not be offered.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.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGES,
• 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: 15810067
• MDR Text Key: 303989221
• Report Number: 1911916-2022-00649
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• 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: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• 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: 2179528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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