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

Catalog Number	309620
Medical Device Problem Codes	Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
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#: unknown it was reported by the customer that unknown substance found in 50ml syringe.Syringe.Is unsterile.Unknown substance found in 50ml syringe.Syringe is unsterile.Additional information: 1.Lot number is 3273719 2.Date was 4-24-24 3.No injury to patient or staff.Item was not used/opened.
Event or Problem Description
No additional information received material: 309620 batch#: 3273719 it was reported by the customer that unknown substance found in 50ml syringe.Syringe is unsterile.Verbatim: unknown substance found in 50ml syringe.Syringe is unsterile.Comments on 25/04/2024 1.Lot number is 3273719 2.Date was 4-24-24 3.No injury to patient or staff.Item was not used/opened.
Additional Manufacturer Narrative
Pr (b)(4) follow up.It was reported an unknown substance was in a 50ml syringe.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows a packaging blister top web and the other photo a syringe in its packaging blister.The syringe barrel flange has foreign matter.No other defects or imperfections were observed.A device history record review was completed for provided material number 309620, lot 3273719.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.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the actual physical sample analysis a probable root cause could not be offered.

• 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: 19219845
• Report Number: 1911916-2024-00300
• Device Sequence Number: 18169205
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: (01)30382903096207
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/03/2024

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: Health Professional
• Device Catalogue Number: 309620
• Device Lot Number: 3273719
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown