MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD ORAL SYRINGE

Catalog Number	305220
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd oral syringe label content was incorrect.The following information was provided by the initial reporter: it was reported by customer that they received product with wrong label having different material number.Verbatim: rcc received a complaint via phone.Pir attached.Product complaint - customer called to report that they received mislabel product, the outer cases is listed as (b)(6) lot 3195317, while (b)(4) bags of a 100ea is label (b)(6), the physical product appears to be the outer carton label.Doe (b)(6) 2024, sample available, not used.No pt harm, customer requests replacement (b)(4) of product.
Additional Manufacturer Narrative
Eight hundred samples and two photos of 3ml clear oral syringes were received by bd.A quality engineer was able to examine the samples and photos from batch 3195317 regarding item 305220.Two box cartons with applicable carton labels with all applicable product information correctly printed with four bags in each consisting of eight sealed bags of 100 count 3ml clear oral syringes with tip caps included material 305220; however, the label on all eight bags is for 10ml clear oral bags material 305219 with batch 3195317.One photo shows the case carton with the case label as described above, and the other shows one bag of 3ml clear oral syringes with a 10ml label as described above.The condition observed is non-conforming per product specification.During this investigation operators, supervisors, and quality associates were interviewed; and technical logs and the production database were reviewed.The in-line labeler had technical issues and off-line printing was utilized also, most likely resulting in a mix-up of the labels.Potential root cause for the label incorrect defect is associated with the packaging process.Most likely operator error resulted in the reported defect.The following corrective actions will be taken: a quality alert will be sent out to the plant: due: 12/31/2024.A device history record review was completed for provided lot number 3195317 showing no other rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.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.
Event or Problem Description
No additional information was provided.

• Brand Name: BD ORAL SYRINGE
• Common Device Name: SYRINGE
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19091076
• Report Number: 1213809-2024-00220
• Device Sequence Number: 12566712
• Product Code: KYW
• UDI-Device Identifier: 50382903052207
• UDI-Public: (01)50382903052207(11)230714(10)3195317
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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 Catalogue Number: 305220
• Device Lot Number: 3195317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown