MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 10ML SYRINGE LUER-LOK TIP BULK CONVENIENCE PAK; PISTON SYRINGE

Model Number 309604

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.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.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.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.

Event Description

It was reported that the bd 10ml syringe luer-lok¿ tip bulk convenience pak experienced device damage while still considered operable.The following information was provided by the initial reporter: no patient involvement, fitting problem, inadequacy of device shape and/or size.

• Brand Name: BD 10ML SYRINGE LUER-LOK TIP BULK CONVENIENCE PAK
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12330477
• MDR Text Key: 266852995
• Report Number: 1911916-2021-00833
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096047
• UDI-Public: 30382903096047
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309604
• Device Catalogue Number: 309604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2021
• 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