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

Catalog Number	306499
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: a device history record review was performed for provided lot number (b)(4).The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, three physical samples and 2 picture samples were received for evaluation by our quality team.Of the 3 samples that were received, two samples have the plunger rod -rubber stopper all the way down.A visual inspection was performed finding no defects or imperfections.The third sample has 5ml of blood, the plunger rod has a separation of 1/16" to the rubber stopper.The 4 photos were provided show the sample received with blood; in one of the photos the plunger rod has been disconnected from the rubber stopper.Investigation conclusion: based on the investigation and with the sample analysis the symptom reported by the customer could not be confirmed.Root cause description: the cause for this defect could have resulted from off label use, as the product is designed to push the plunger rod down while expelling the solution, versus being pulled back to collect blood.Rationale: we will continue monitoring the complaint trend for this product and symptom.
Event or Problem Description
It was reported that the stopper separated from the bd posiflush¿ sf saline syringe plunger while flushing a picc line.The following information was provided by the initial reporter: "flushing a picc line and drawing for waste when a plunger became disconnected from inside the syringe.No resistance prior to occurrence.New syring connected to complete the flushing for lab collection.Same thing occurred to two of the same (lot) syringes.Customer stated there was no issue reported regarding the picc.".

• Brand Name: BD POSIFLUSH SF SALINE SYRINGE
• Common Device Name: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11115037
• Report Number: 1911916-2020-01168
• Device Sequence Number: 3698421
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: 00382903064991
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (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): 12/22/2020

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: 03/31/2022
• Device Catalogue Number: 306499
• Device Lot Number: 9080892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1