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	01/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 9000 bd enteral syringes had illegible scale markings.The following information was provided by the initial reporter: " the customer indicates that the syringes have a blurred scale in the indicated lot.".
Additional 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 or Problem Description
It was reported that 9000 bd enteral syringes had illegible scale markings.The following information was provided by the initial reporter: " the customer indicates that the syringes have a blurred scale in the indicated lot.".
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: forty physical samples of 10ml oral/enteral sealed packages (p/n 305857) batch 1025001 were received and evaluated.All forty of the samples have severe ink smears on the major and minor grad lines in two or three different areas.The observed condition is 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.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.
Event or Problem Description
It was reported that 9000 bd enteral syringes had illegible scale markings.The following information was provided by the initial reporter: "the customer indicates that the syringes have a blurred scale in the indicated lot.".

• 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: 13455300
• Report Number: 1213809-2022-00048
• Device Sequence Number: 17300150
• Product Code: KNT
• UDI-Device Identifier: 30382903058571
• UDI-Public: 30382903058571
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 03/02/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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