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

Catalog Number 302830

Device Problem Difficult to Advance (2920)

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

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history review could not be completed as no batch number was provided.

Event Description

It was reported that the bd¿ syringe with bd luer-lok¿ tip had difficult plunger movement.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD¿ SYRINGE WITH BD LUER-LOK¿ TIP
• Type of Device: PISTON 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: 7919000
• MDR Text Key: 122196765
• Report Number: 1911916-2018-00558
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028307
• UDI-Public: 30382903028307
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302830
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• 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