MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH HEPARIN SYRINGE; HEPARIN, VASCULAR ACCESS FLUSH

Model Number	306413
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: it was reported that the nurse attempted to prime the syringe the plunger became dislodged from the seal.To aid in the investigation, one sample in a plastic bag, with no packaging flow wrap, was received for evaluation by our quality team.A visual inspection was performed.The rubber stopper is at the 2ml mark of the scale 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 the customer is not using the product as intended.This product is designed to push the plunge rod-rubber stopper down.It is not designed to pull back.A device history record review was completed for provided material number 306413, lot number 111614n.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.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 or Problem Description
It was reported that the bd posiflush¿ heparin syringe experienced difficult plunger movement.The following information was provided by the initial reporter: as the nurse attempted to prime the syringe the plunger became dislodged from the seal.It expected that the heparin syringe plungers are sticky and have to loosen it by pulling it out then in.In this case this plunger became dislodged while the nurse was doing this.The nurse got a new heparin syringe and this issue did not reach the pt.

• Brand Name: BD POSIFLUSH HEPARIN SYRINGE
• Common Device Name: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12674562
• Report Number: 1911916-2021-01096
• Device Sequence Number: 11836954
• Product Code: NZW
• UDI-Device Identifier: 30382903064138
• UDI-Public: 30382903064138
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K163591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 306413
• Device Catalogue Number: 306413
• Device Lot Number: 111614N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1