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

Model Number 306546

Device Problems Fungus in Device Environment (2316); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that foreign "mildew-like" substance was found on the bd posiflush¿ normal saline syringe tip before use.The following information was provided by the initial reporter: "health professional called in to report that they found a foreign mildew-like substance on the tip of the syringe prior to use.".

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 0148634.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, 1 picture and 1 physical sample was received for evaluation by our quality team.Through examination of the sample, a visual inspection was completed for the physical sample, and the tip cap had foreign matter.The sample was sent to a lab for analysis and the lab confirmed the foreign matter is not mold, and the matter was confirmed to be embedded degraded resin.The picture sample shows the physical sample that was received.The cause for this defect could have resulted during the molding process where the resin can build up on the hot runner system, break loose and become molded into the components.H3 other text : see h.10.

Event Description

It was reported that foreign "mildew-like" substance was found on the bd posiflush¿ normal saline syringe tip before use.The following information was provided by the initial reporter: "health professional called in to report that they found a foreign mildew-like substance on the tip of the syringe prior to use.".

• Brand Name: 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
• MDR Report Key: 10655996
• MDR Text Key: 213235690
• Report Number: 1911916-2020-00944
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 0148634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other