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

Catalog Number 309653

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

Summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.Root cause: root cause is undetermined.

Event Description

It was reported there was difficult plunger movement while using a 60 ml bd¿ syringe with bd luer-lok¿ tip.The user reported to have a "difficult time holding the syringe with one hand and pulling it back." there was no report of exposure, serious injury or medical intervention.

• Brand Name: BD¿ SYRINGE WITH BD LUER-LOK¿ TIP
• Type of Device: 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: 7462383
• MDR Text Key: 106727073
• Report Number: 1911916-2018-00198
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: 30382903096535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309653
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2017
• 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