MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ SP SYRINGE; SALINE FLUSH

Catalog Number 306575

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).Results: a complaint history check was performed and this is the first related complaint reported for the defect/condition on lot number 6350856.This lot number and incident will be monitored for future occurrences.Conclusion: an absolute root cause for this incident cannot be determined.Udi #: (b)(4).

Event Description

It was reported that the plunger movement was difficult in a 10 ml bd posiflush¿ sp syringe in the last 4 ml.No injury or medical intervention.

• Brand Name: 10 ML BD POSIFLUSH¿ SP 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: 6753178
• MDR Text Key: 81489008
• Report Number: 1911916-2017-00156
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 306575
• Device Lot Number: 6350856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2016
• 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