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

Catalog Number	309620
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 309620, batch#: 4247871.Rcc received a complaint via email.Syringe tip broke off.
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.
Additional Manufacturer Narrative
E and f code updated e2403 - no clinical signs, symptoms or conditions.F26 - no health consequences or impact.
Event or Problem Description
Customer response on (b)(6) 2025.There was no report of patient harm.
Event or Problem Description
Additional information received.There was no report of patient harm.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation: it was reported the syringe tip broke off.To aid in the investigation, one sample with no packaging blister was received for evaluation by our quality team.A visual inspection was performed, and the syringe barrel tip is broken off.The breakage surface is irregular, and the bottom part of the syringe barrel has a crack that starts at the syringe barrel tip.No other defects or imperfections were observed.Breaking the barrel tip would require force that could induce the barrel crack during use.A device history record review was completed for provided material number 309620, lot 4247871.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Associates were shown the sample and have not observed this type of damage during manufacturing processes.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is 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: 21167270
• Report Number: 1911916-2025-00018
• Device Sequence Number: 14603330
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: (01)30382903096207(11)240905(17)290831(10)4247871
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNK
• 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,Followup
• Report Date (Section B): 01/24/2025

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: 4247871
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: Not provided; 01/24/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 01/21/2025; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown