MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 30 ML BD LUER-LOK¿ TIP SYRINGE; HYPODERMIC SYRINGE

Catalog Number 302832

Device Problems Out-Of-Box Failure (2311); Mushroomed (2987)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.Results: a complaint history check was performed and this is the first related complaint reported for the defect/condition on lot number 6327688.Incident samples were not returned from the customer or the customer discarded the samples for investigational purposes.This lot number and incident will be monitored for future occurrences.The complaint file will be reopened for testing of samples if received at a later date.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.(b)(4).

Event Description

It was reported that dust or mold particles were found inside the syringe and packaging of a 30 ml bd luer-lok¿ tip syringe.No injury or medical intervention.

• Brand Name: 30 ML BD LUER-LOK¿ TIP SYRINGE
• Type of Device: HYPODERMIC SYRINGE
• 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: 6751164
• MDR Text Key: 81492465
• Report Number: 1911916-2017-00157
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 302832
• Device Lot Number: 6327688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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