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

Catalog Number 306595

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation results: summary: a sample was received by bd for evaluation.A quality engineer was able to inspect the sample and determined that the barrel flange was damaged thus verifying the reported issue.This can be caused by the plunger rod labeler experiencing a slight variation in how it operated.The engineer investigated the labeler and made any necessary adjustments to ensure that it was operating according to specifications.A device history review was performed on the reported lot and found that zero defects were noted during this production run.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Conclusion: dhr/bhr review there was no documentation of issues for the complaint of batch 7139546 during this production run.Investigation comments: all our inspections and testing performed while manufacturing this batch were accepted.April 26, 2018, a sample was received.It has opened the packaging flow wrap.It has the plunger rod-rubber stopper, the tip cap, and the saline solution, the barrel label confirms the lot# 7139546.The barrel flange is damaged.Product within specification? yes? no? capa not required for this event.Root cause: the plunger rod labeler equipment possibly experienced a variation.Anyway, adjustments have been verified.

Event Description

It was reported a nurse found the flange damaged on a bd posiflush¿ normal saline syringe prior to use.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7505056
• MDR Text Key: 108157857
• Report Number: 1911916-2018-00186
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 306595
• Device Lot Number: 7139546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other