MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 20 ML BD SYRINGE WITH BD LUER-LOK¿ TIP .; 20ML HYPODERMIC SYRINGE

Catalog Number 302830

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

Results: samples were not received for evaluation.The customer provided a photo which confirmed the presence of a black ring on the syringe barrel.A review of the device history records could not be performed as a lot number for this incident was not provided.Conclusions: although the provided photos confirmed the customer's failure mode, without the actual sample to examine, a root cause for this incident could not be identified.(b)(4).

Event Description

The anesthesiologist was using the 20 ml bd syringe with bd luer-lok¿ tip and found black rings from the rubber plunger inside the syringes while drawing up medication.

• Brand Name: 20 ML BD SYRINGE WITH BD LUER-LOK¿ TIP .
• Type of Device: 20ML 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: 6724564
• MDR Text Key: 80564497
• Report Number: 1911916-2017-00047
• 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: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 302830
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2017
• 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