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

Catalog Number 306546

Device Problems Mechanical Problem (1384); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that while using a 10 ml bd posiflush¿ normal saline syringe, the user was only able to push the plunger to the 5 ml mark.They experienced plunger difficulty.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: a sample was received for evaluation.It came in a ziploc plastic bag for biohazard material.It has no packaging flow wrap, no tip cap and no saline solution.It has the plunger rod-rubber stopper.The barrel label confirms the lot#7333606.The rubber stopper was at the 3ml mark scale.It was tested for sustaining force giving 15.45 n, the specification is <20n therefore failure mode is not verified.Root cause could not be determined.There were no quality notifications issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.A device history review was completed with no issues associated with customer complaint during this production batch.All our inspections performed while manufacturing this batch were accepted; no rejections were documented.Root cause could not be determined because the returned device tested within specification.There was no issue documented about plunger movement difficult.It was determined that a capa is not required for this event.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7392757
• MDR Text Key: 104419919
• Report Number: 1911916-2018-00120
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 306546
• Device Lot Number: 7333606
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other