MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD ENTERAL SYRINGES; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number	305857
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd enteral syringe experienced scale marking issues.The following information was provided by the initial reporter: no or half erased scale lines on the injector.We cannot scale.
Additional Manufacturer Narrative
Investigation summary: one photo of a loose 10ml syringe (p/n (b)(4) was received and evaluated.The print condition observed was non-conforming per product specification.Potential root cause for the ink smearing defect is associated with the marking process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #1025001 is considered in compliance with our product specification requirements.Furthermore, 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.Potential root cause for the ink smearing defect is associated with the marking process.The aql for ink smears is 0.25%.The defective rate identified is 1 out of 419,200 which is 0.0002%.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #1025001 is considered in compliance with our product specification requirements.
Additional Manufacturer Narrative
Investigation summary: one photo of a loose 10ml syringe (p/n 305857) was received and evaluated.The print condition observed was non-conforming per product specification.Potential root cause for the ink smearing defect is associated with the marking process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #1025001 is considered in compliance with our product specification requirements.Furthermore, 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.Potential root cause for the ink smearing defect is associated with the marking process.The aql for ink smears is 0.25%.The defective rate identified is (b)(4) which is (b)(4).These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #1025001 is considered in compliance with our product specification requirements.
Event or Problem Description
It was reported that the bd enteral syringe experienced scale marking issues.The following information was provided by the initial reporter: no or half erased scale lines on the injector.We cannot scale.

• Brand Name: BD ENTERAL SYRINGES
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13225973
• Report Number: 1213809-2021-00859
• Device Sequence Number: 14494323
• Product Code: KNT
• UDI-Device Identifier: 30382903058571
• UDI-Public: 30382903058571
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K112434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2026
• Device Model Number: 305857
• Device Catalogue Number: 305857
• Device Lot Number: 1025001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown