MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO GENERAL PURPOSE SYRINGE BD LUER-LOK¿; PISTON SYRINGE

Model Number 309604

Device Problem Leak/Splash (1354)

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

Event Date 07/13/2022

Event Type  malfunction  

Event Description

It was reported that while using the general purpose syringe bd luer-lok¿ the syringe barrel was damaged the following information was provided by the initial reporter, translated from japanese to english: the syringe barrel was damaged during use.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were corrected due to partial evaluation of the sample: d3.Medical device manufacturer: cuautitlan, mx.G1: manufacturing location: cuautitlan, mx.H6: investigation summary.Photos received by our quality team for investigation.Upon visual inspection, cracked barrel is observed, therefore the failure is confirmed.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.The sample was received by bd canaan and it was determined by looking at the mold that it was made by bd's plant in cuautitlan, mx.The samples were shipped there.When the package arrived in cuautitlan the samples were missing, and therefore they cannot be evaluated.

Event Description

It was reported that while using the general purpose syringe bd luer-lok¿ the syringe barrel was damaged.The following information was provided by the initial reporter, translated from japanese to english: the syringe barrel was damaged during use.

• Brand Name: GENERAL PURPOSE SYRINGE BD LUER-LOK¿
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli CT 06018
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15191020
• MDR Text Key: 304921272
• Report Number: 1213809-2022-00468
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096047
• UDI-Public: 30382903096047
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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