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

Model Number 309628

Device Problems Break (1069); Leak/Splash (1354); Volume Accuracy Problem (1675)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The customer's address is unknown.Unknown, new jersey, 00000 usa has been used as a default.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the flanges on the bd luer-lok¿ tip syringe were bent and damaged, and the scale markings were off "by a centimeter or so".The following information was provided by the initial reporter: "they said the scale marking appeared to be shifted and ¿bent¿ flanges.The observation appears to have been made at point of use." "the reporter stated the barrel flange or finger flange got overheated and was bent.The syringe was fully intact but seems like during the making of the syringe, it got bent.For the same syringe, the volume markings on the end of the syringe is incorrect.The markings were off by a centimeter or so.Therefore, the amount of medication delivered would be incorrect.The eylea vial was used but another bd syringe was used instead.".

Event Description

It was reported that the flanges on the bd luer-lok¿ tip syringe were bent and damaged, and the scale markings were off "by a centimeter or so".The following information was provided by the initial reporter: "they said the scale marking appeared to be shifted and ¿bent¿ flanges.The observation appears to have been made at point of use." "the reporter stated the barrel flange or finger flange got overheated and was bent.The syringe was fully intact but seems like during the making of the syringe, it got bent.For the same syringe, the volume markings on the end of the syringe is incorrect.The markings were off by a centimeter or so.Therefore, the amount of medication delivered would be incorrect.The eylea vial was used but another bd syringe was used instead.".

Manufacturer Narrative

H6: investigation summary: three photos were received and evaluated.The photos showed a single loose 1ml ll syringe with customer¿s label attached a top an eylea kit.The scale was observed to not be printed correctly on the barrel with a high zero line condition.One flange of the barrel was observed to bent up and one flange was bent down.Potential root cause for the improperly printed scale defect is associated with the marking process.It is possible that the bent flange led to a misalignment of the barrel in the marker resulting in the misprinted scale observed.A bent flange detector at the marker was installed end of jun 2020, after this batch was manufactured.No further actions are required.No additional actions are necessary based on the defective rate identified.Batch 9051805 is considered in compliance with our product specification requirements.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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 h10.

• Brand Name: BD LUER-LOK TIP SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12439333
• MDR Text Key: 270309350
• Report Number: 1213809-2021-00620
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: 9051805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1