MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE CATHETER TIP 50ML; SYRINGE, IRRIGATING (NON DENTAL)

Catalog Number	309620
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material #:309620.Batch#:4172759.It was reported by customer that they found a punctures in plastic packaging.Verbatim: rcc received a complaint via email.Please follow up with (b)(6) for the product concern outlined below within 3 business days; and advise of any special shipping instructions for pick up, courier or discarding of product.Please investigate and follow up with a written report from your quality assurance as to your findings and resolutions.Product concern ticket number: (b)(4).Date of incident: (b)(6) 2024.Hospital: (b)(6).Department: (b)(6).Product: syr ll tip 50cc.Vmid: (b)(4).Lot number: multiple lots.Product expiry date: 31-may-2029.Number of defective product(s): 1.Is sample available: no.Concern description: looks like small punctures in plastic packaging.Thank you in advance for your follow-up on this product concern.
Additional Manufacturer Narrative
Pr (b)(4) follow up.It was reported there are punctures in the plastic packaging.To aid in the investigation, one photo was received for evaluation by our quality team.The photo shows a packaging blister bottom web with rounded marks from the packaging process; they are not holes.No other information could be obtained from the photo.A device history record review was completed for provided material number 309620, lot 4172759.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported condition.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation with the photo sample analysis the symptom reported by the customer could not be confirmed.

• Brand Name: SYRINGE CATHETER TIP 50ML
• Common Device Name: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21885185
• Report Number: 1911916-2025-00299
• Device Sequence Number: 3434612
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: (01)30382903096207(11)240620(17)290630(10)4172759
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: Health Professional
• Device Catalogue Number: 309620
• Device Lot Number: 4172759
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown