MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ LUER-LOK SYRINGE 60 ML; HYPODERMIC NEEDLE

Lot Number 4119643

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 4119643, medical device expiration date: 4/30/2019, device manufacture date: 4/1/2014.Medical device lot #: 5076884, medical device expiration date: 03/31/2020, device manufacture date: 3/1/2015.Medical device lot #: 5076918, medical device expiration date: 03/31/2020, device manufacture date: 3/1/2015.Results: we were unable to perform a thorough investigation, as no samples displaying the reported defect are available for examination.A device history record review was performed on all three lot numbers and no issues for excessive silicone were recorded during the manufacturing of this product.All three lot numbers were within specification of silicone.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.(b)(4).

Event Description

It was reported that excessive fluid/moisture was found in the 60ml bd¿ luer-lok syringe before use.There was no report of injury or medical interventions.

• Brand Name: BD¿ LUER-LOK SYRINGE 60 ML
• Type of Device: HYPODERMIC NEEDLE
• 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: 6742605
• MDR Text Key: 81124140
• Report Number: 1911916-2017-00137
• 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: 07/25/2017

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: Other
• Device Lot Number: 4119643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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