MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SP SYRINGE; SALINE FLUSH

Catalog Number 306575

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd posiflush¿ sp syringe had foreign matter in it.This was discovered before use.The following information was provided by the initial reporter: material no: 306575, batch no: 8360794.It was reported that tip of syringe has a red substance on it.

Manufacturer Narrative

Investigation summary: one sample was received for evaluation.It has no packaging flow wrap.The luer tip and the tip cap show residues of brownish foreign matter.Additionally, one photo was provided.It shows the luer and the tip cap removed from the syringe.It shows the foreign matter on both the luer and the tip cap.The sample was sent to a lab for a ftir.The lab report was received and confirmed that the foreign matter is blood.Root cause could not be determined.The sample was received in opened packaging.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.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 Description

It was reported that bd posiflush¿ sp syringe had foreign matter in it.This was discovered before use.The following information was provided by the initial reporter: material no: 306575 batch no: 8360794 it was reported that tip of syringe has a red substance on it.Awaiting translation.

• Brand Name: BD POSIFLUSH¿ SP SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8713402
• MDR Text Key: 149225736
• Report Number: 1911916-2019-00602
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 306575
• Device Lot Number: 8360794
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other