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

Catalog Number 306594

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

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

Event Date 04/17/2018

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 bd posiflush¿ syringe there was an issue with a damaged device.It was stated ¿the nurse found the flange damaged when the plastic package was opened.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation results: investigation summary: customer returned (139) 3/10cc, 8mm, 31g relion syringes in open poly bags from lot # 7205916.Customer states that the markings seems to be off-center and crooked.Thirty out of 139 returned syringes were tested using the plug gauge and the placement of the scale markings on the barrel fell within specifications.A review of the device history record was completed for batch # 7205916.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were two (2) notifications [200710679, 200710678] noted for missing print.There was one (1) notification [200711253] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for scale misaligned on lot # 7205916.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Based on the above, no additional investigation and no capa is required at this time.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.

• Brand Name: BD POSIFLUSH¿ 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: 7451587
• MDR Text Key: 106632947
• Report Number: 1911916-2018-00187
• 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,Followup
• Report Date: 04/30/2018

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: 06/30/2020
• Device Catalogue Number: 306594
• Device Lot Number: 7199991
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 04/18/2018
• Supplement Dates FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• 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