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

Catalog Number 309653

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: four units were received for evaluation.Our quality engineer visually inspected the returned units and confirmed the presence of clear liquid drops along the roofs of the syringe barrels.The engineer identified the foreign as most likely being excess silicone.Conclusion: silicone is an inert, nontoxic medical substance used as a lubricant for disposable hypodermic products.It does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Then, when the plunger is fully depressed, the silicone gets distributed along the barrel roof and walls, ensuring a lubricated surface for the plunger to move against.However, in this case, there was an unusual aggregation of silicone on the barrel roof area which created the noticeable appearance.(b)(4).

Event Description

When the customer was going to draw up some chemo medication, she noticed that the 60ml bd syringe with bd luer-lok¿ tip had some condensation already in the tip of the syringe.Six others in stock were found to be affected.

• Brand Name: 60ML BD SYRINGE WITH BD LUER-LOK¿ TIP
• 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: 6751437
• MDR Text Key: 81474587
• Report Number: 1911916-2017-00182
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• 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: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 309653
• Device Lot Number: 6354504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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