MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE CATHETER TIP 50ML; SYRINGE, IRRIGATING (NON DENTAL)

Catalog Number	309620
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 by the customer that they received a syringe with some residue on the inside.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.A syringe was reported to contain internal residue.To support the investigation, the quality team received one sample in a sealed blister package and three photographs for evaluation.A visual inspection was performed, and a stain consistent with equipment lubricant was observed on the bottom web of the packaging blister.The three photographs provided depict the sample as received.No additional defects or imperfections were noted.This condition could occur if equipment lubricant residues were not fully removed following equipment maintenance or repair.A device history record review was completed for material number 309620, lot 5212902.The review did not identify any quality issues detected during production that would have contributed to the reported condition, and no related quality notifications were found.All manufacturing processes and final inspections met applicable specification requirements.The sample will be shared with associates for awareness.To date, no other similar events have been reported for this lot.Based on the investigation and the returned sample evaluation, the customer reported condition is confirmed.

• Brand Name: 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: 24817151
• Report Number: 1911916-2026-00163
• Device Sequence Number: 20336365
• Product Code: KYZ
• UDI-Device Identifier: 00382903096206
• UDI-Public: (01)00382903096206(11)250801(17)300731(10)5212902
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: 5212902
• 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: 04/03/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown