MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ 1-ML SYRINGE; PISTON SYRINGE

Catalog Number 309628

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.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.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.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.H3 other text: see h.10.

Event Description

It was reported while using bd luer-lok¿ 1-ml syringe the plunger rod bent.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: the quality seems to have deteriorated in the past, so that the plunger bends or even breaks! it is not possible to define exactly when the case occurred for the first time, but it has become more noticeable in the last 2-3 months.X-ray contrast medium solutrast 300 and embolisation particles for angiographic interventions were administered.Both were injected via microcatheter and during this procedure the plunger bent or broke off.Patients were not harmed, but material consumption was higher and examination time increased because new syringes had to be fetched.Almost every syringe that was used with increased pressure was affected.

• Brand Name: BD LUER-LOK¿ 1-ML SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17647417
• MDR Text Key: 322269793
• Report Number: 1213809-2023-00930
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: (01)00382903096282
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K941562
• 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
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309628
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• 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