MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; FLUSH SYRINGE

Catalog Number 306595

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 11/01/2018

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.

Event Description

It was reported with the use of the 10 ml bd posiflush¿ normal saline syringe there was an issue with sharp protrusions.There was no report of injury or medical intervention.

Event Description

It was reported with the use of the 10 ml bd posiflush¿ normal saline syringe there was an issue with sharp protrusions.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: two photos were received.One photo shows the syringe with packaging flow wrap, and the other one without it; it has the plunger rod-rubber stopper, the saline solution.The photos do not show the tip cap area and the barrel label.The barrel flange is damaged.This is the fourth complaint for lot # 7208538 for this type of defect or symptom.Dhr review showed there was no documentation for this type of defect during the entire production run of this batch.Investigation conclusion: the photos shows the barrel flange damaged.Root cause description: this type of damage most likely was induced by a process variation of the plunger rod label machine.Rationale: prl equipment variation; the capa 390709 has been opened.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8080119
• MDR Text Key: 127565400
• Report Number: 1911916-2018-00654
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K982558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• 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: 306595
• Device Lot Number: 7208538
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other