MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 5ML CLEAR STERILE; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number 305855

Device Problem Volume Accuracy Problem (1675)

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

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: one 5ml syringe (material 305855) was received inside a partially open blisterpak from batch 8312933.The sample was visually evaluated.No barrel damage, deformities or any other defects were found.The sample was then measured for barrel inside diameter per applicable internal procedure and yielded results within product specification range.The syringe was acceptable per product specification.Device history record review: all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 8312933 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.A complaint history check was performed no additional complaint reported with the defect/condition of inner diameter / outer diameter out of specification with batch 8312933 regarding material 305855.A trend review was performed no additional complaint reported with the defect/condition of inner diameter / outer diameter out of specification regarding material 305855.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.Investigation conclusion: since the reported condition was not identified in the sample received corrective actions are not necessary.

Event Description

It was reported that the syringe oral 5ml clear sterile experienced syringe volumetric accuracy issues.The following information was provided by the initial reporter: unfortunately our lab group is running into issues with the outside diameters on two enteral syringes.Our measurements are showing that both are out of spec with the od too large.Since the pumps measure the od and use it to determine what size syringe is loaded this discrepancy is causing issues with the pump's ability to identify the syringe.I should note this is something we're seeing in our lab.

Event Description

It was reported that the syringe oral 5ml clear sterile was involved with the device operator experiencing general dissatisfaction.The following information was provided by the initial reporter: unfortunately our lab group is running into issues with the outside diameters on two enteral syringes.Our measurements are showing that both are out of spec with the od too large.Since the pumps measure the od and use it to determine what size syringe is loaded this discrepancy is causing issues with the pump's ability to identify the syringe.I should note this is something we're seeing in our lab.

Manufacturer Narrative

This event has been corrected to be a case of general dissatisfaction.General dissatisfaction of the product does not impact the intended use of the device which does not lead to harm or serious injury to the clinician or patient.This report and the initial mdr submission associated with it, (mfr report # 1213809-2021-00470), may therefore be disregarded.

• Brand Name: SYRINGE ORAL 5ML CLEAR STERILE
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12108096
• MDR Text Key: 267248744
• Report Number: 1213809-2021-00470
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 30382903058557
• UDI-Public: 30382903058557
• Combination Product (y/n): N
• PMA/PMN Number: K112434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 305855
• Device Catalogue Number: 305855
• Device Lot Number: 8312933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Distributor Facility Aware Date: 07/02/2021
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1