MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SF SALINE SYRINGE; INTRAVASCULAR CATHETER

Catalog Number	306499
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the stopper in the bd posiflush¿ sf saline syringe was "thicker" at the end, and the pre-filled solution was "about.4 ml's" under specification.All defects were found during use.The following information was provided by the initial reporter: "the issue is that we have a new version of the posiflush syringe where the rubber stopper at the end is thicker than the previous one, and i was wondering if the dimensions on the new posiflush syringe are different than the old model.Because the ones from the new lot are reading about.4 ml's under.".
Additional Manufacturer Narrative
Investigation: two samples were received.One sample is a 306499 and the other one is a 306500.Both came in sealed packaging.Visual inspection was performed finding them both acceptable with no defects.They are different product designs; therefore, the stoppers are different.The 306500 is not anymore produced by our company.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
Event or Problem Description
It was reported that the stopper in the bd posiflush¿ sf saline syringe was "thicker" at the end, and the pre-filled solution was "about.4 ml's" under specification.All defects were found during use.The following information was provided by the initial reporter: "the issue is that we have a new version of the posiflush syringe where the rubber stopper at the end is thicker than the previous one, and i was wondering if the dimensions on the new posiflush syringe are different than the old model.Because the ones from the new lot are reading about.4 ml's under.".

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9295924
• Report Number: 1911916-2019-01171
• Device Sequence Number: 19337794
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: 00382903064991
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 306499
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other