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

Catalog Number 309653

Device Problems Out-Of-Box Failure (2311); Device Disinfection Or Sterilization Issue (2909); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

Results: one unit was received for evaluation.Our quality engineer visually inspected the returned unit and confirmed the presence of a piece of plastic in the syringe barrel.A complaint history check revealed no similar incidents for reported lot number 6217940.Conclusions: bd was able to confirm the indicated failure.The plastic was identified as most likely being polypropylene, the same material the barrels are made from.(b)(4).

Event Description

The customer noticed a large piece of plastic inside the barrel of a 60ml bd syringe with bd luer-lok¿ tip when withdrawing medication from a vial.The single use syringe had been removed from its sterile packaging immediately before use.

• 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: 6751212
• MDR Text Key: 81474355
• Report Number: 1911916-2017-00071
• 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: health professional,other,use
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/20/2017

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: 08/31/2021
• Device Catalogue Number: 309653
• Device Lot Number: 6217940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• 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