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

Catalog Number 306574

Device Problems Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation results: summary: 12 photos were received for evaluation by one of our quality engineers.Case box label, shelf box label and barrel label confirm the lot# 7291824.The photos show the packaging flow wrap damaged/torn towards the end where the plunger rod thumb press is therefore failure mode is verified.While root cause could not be definitively determined, it is possible that the packaging was exposed to excessive compression force during handling or transportation inducing damages to the shelf box and packaging flow wrap.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.A device history review indicated that there was no documentation of issues for the complaint of batch 7291824 during this production run.Conclusion: investigation comments: all our inspections and testing performed while manufacturing this batch were accepted.No rejections were documented.On (b)(6) 2018.Twelve (12) photos were received.Case box label and shelf box label and barrel label confirm the lot# 7291824.The photos show the packaging flow wrap damaged/torn towards the end where the plunger rod thumb press is.Product within specification? ¿ yes ¿ no root cause: root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections and testing were accepted during the production of this batch.Possible root cause.Handling/ transportation.Possible the packaging was exposed to excessive compression force inducing damages to the shelf box and packaging flow wrap.

Event Description

It was reported the packaging on a bd posiflush¿ saline syringe was found torn/damaged prior to use.There was no report of exposure, injury or medical intervention.

• 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
• 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: 7594027
• MDR Text Key: 111323584
• Report Number: 1911916-2018-00276
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K011982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 306574
• Device Lot Number: 7291824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2017
• 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