MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 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	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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 syringe catheter tip 50ml package was damaged / defective.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached 50 ml syringe catheter tip ref (b)(4).Lot 5121908 issue: there is a dominant black tape over the item packaging and the syringes with this type of tape are not sealed properly.This item could not be used to due to concern of quality, cleanliness, and patient safety.It was within the same package of others and other syringes in the same box did not look dirty or affected.Additional information provided: for (b)(4).I was given the item on 11/04/2025.2.Correct lot # 5171908 3.There was no damage to the box.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported that a dominant black tape was present on the item packaging, and the syringes with this tape were not sealed properly.To support the investigation, four samples and two photographs were provided for evaluation by the quality team.Three samples were in sealed packaging blisters, while one sample was in an opened blister.A visual inspection revealed that the top webs of the packaging blisters had dark-colored tape applied to both sides.The photographs correspond to the samples received.No additional defects or imperfections were observed.This condition may occur during the splicing of two top web rolls if the affected units were not removed from the production flow.A device history record review was conducted for material number 309620, lot 5171908.The review did not identify any quality issues during production that could have contributed to the reported condition, nor were there any related quality notifications.All processes and final inspections were performed in accordance with specification requirements.The samples will be shared with associates for awareness.To date, no similar events have been reported for this lot.Based on the investigation and analysis of the returned samples, the customer¿s reported condition has been confirmed.

• Brand Name: BD SYRINGE CATHETER TIP 50ML
• Common Device Name: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 23756295
• Report Number: 1911916-2025-00782
• Device Sequence Number: 13157693
• Product Code: KYZ
• UDI-Device Identifier: 00382903096206
• UDI-Public: (01)00382903096206
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2025

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: 5171908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/13/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown