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

Catalog Number 306574

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation results: summary: a total of 15 photos were received for evaluation by our quality engineers.Photos show the case label and the shelf box label confirming the lot#7291824.Photos show a shelf box which experienced excessive compression force.There are other photos showing syringes in their packaging flow wrap.The packaging flow wrap is torn on the plunger rod thumb press side.Failure mode is verified.Based on the photos the packaging was likely exposed to excessive compression force inducing damage to the shelf box and packaging flow wrap during handling and transportation.A device history review was completed and there was no documentation of issues for the complaint of batch (b)(4) during this production run.There were no quality notifications issued during the production of this batch listed in the complaint.Conclusion: investigation comments: all our inspections and testing performed while manufacturing this batch were accepted.No rejections were documented.(b)(6) 2018; 15 photos were received.Photos show the case label, the shelf box label confirming the lot#7291824.Photos show a shelf box which experienced excessive compression force.There are other photos showing syringes in their packaging flow wrap.The packaging flow wrap is torn on the plunger rod thumb press side.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.Based on the photos the packaging was exposed to excessive compression force inducing damaged to the shelf box and packaging flow wrap.

Event Description

It was reported some of individual packaging was found open on a box of 5 ml bd posiflush¿ saline syringes prior to use.There was no report of exposure, serious 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: 7541444
• MDR Text Key: 109304552
• Report Number: 1911916-2018-00231
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• 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: 05/04/2018
• 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