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

Catalog Number 306574

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: bd received two 5ml saline syringes from the reported lot, 7206569, for evaluation.Our quality engineer was able to visually inspect the returned samples and observed a brownish material embedded in the barrel and luer tip.Next, the engineer performed ftir analysis on the embedded foreign matter (fm) by removing a small piece of fm and testing it.The results indicated that the material was most likely a piece of valve material or polyisoprene along with chlorinated polyethylene.Based off of the results of the visual inspection and ftir the engineer was able to verify the reported issue of foreign matter.The fm was confirmed to have come from a valve used in the resin drying process that was deteriorated and inducing foreign matter.The source of the fm was removed and replaced with a new valve.There was documented embedded fm on one of the inspections performed during the production run for batch 7206569.The molding barrel accumulator, rail conveyors and the packaging area were cleared by scrapping all components and the syringes.Also a stat sampling was performed and passed with zero found.

Event Description

It was reported with the use of the bd posiflush¿ saline syringe there was an issue with foreign matter.There was no report of injury or further medical intervention.

Manufacturer Narrative

Correction for reason code for no evaluation and if other specify.The following field(s) have been updated.If follow up what type? yes, yes, no.

Event Description

It was reported with the use of the bd posiflush saline syringe there was an issue with foreign matter.There was no report of injury or further medical intervention.

Event Description

It was reported with the use of the bd posiflush¿ saline syringe there was an issue with foreign matter.There was no report of injury or further medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.

• Brand Name: BD POSIFLUSH¿ SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7748884
• MDR Text Key: 116051702
• Report Number: 1911916-2018-00432
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K011982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 306574
• Device Lot Number: 7206569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other