MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE 100ML CATH TIP; PISTON SYRINGE

Catalog Number 300605

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); Skin Tears (2516)

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that 50 bd syringe 100ml cath tip had sharp molding.The following information was provided by the initial reporter: "it was noted that the catheter tip has so sharp edges that it hurts/tears the skin from the ear canal of the patient".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-15.H6: investigation summary one sample received for investigation.Upon visual inspection of the sample received, no molding defects, damage or burrs can be observed in the syringe tip.A device history review was performed and found no non-conformances associated with this issue during the production of lot 2006200, all product was manufactured according to specification.Tip of the syringe has been inspected with the microscope not finding any characteristic out of specification.Retained samples were used for additional evaluation.There were no visual defects noted and in all cases the product performed as expected.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.

Event Description

It was reported that 50 bd syringe 100ml cath tip had sharp molding.The following information was provided by the initial reporter: "it was noted that the catheter tip has so sharp edges that it hurts/tears the skin from the ear canal of the patient".

• Brand Name: BD SYRINGE 100ML CATH TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12965303
• MDR Text Key: 285389800
• Report Number: 3003152976-2021-00808
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NA
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 300605
• Device Lot Number: 2006200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2020
• 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