MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE, IRRIGATING (NON DENTAL); SYRINGE, PISTON

Catalog Number	408531
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 408531; batch#: 2222712.Verbatim: black particle.Additional information: did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? it was found during product processing, but prior to using the cap (found during inspection of the supply).2.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.
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
No additional information.
Additional Manufacturer Narrative
Two photos were received for investigation.Through visual inspection, it is observed in the photo a white female cap in an open blister and in the top part a dark mark is seen; in the 2nd photo a dark mark is seen inside the cap.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Possible root cause is associated with operator error during the manual load and fed of product into the blister pocket foreign matter.Manufacturing personnel have been notified of this incident to increase awareness of this matter.Manufacturing personnel have been notified of this incident to increase awareness of this matter.
Additional Manufacturer Narrative
Two photos were received for investigation.Through visual inspection, it is observed in the photo a white female cap in an open blister and in the top part a dark mark is seen; in the 2nd photo a dark mark is seen inside the cap.Additionally, one sample received for investigation.Through visual inspection, foreign matter can be observed, additional testing was performed, foreign substance is likely cardboard, or paper.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Possible root cause is associated with operator error during the manual load and fed of product into the blister pocket foreign matter.Manufacturing personnel have been notified of this incident to increase awareness of this matter.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: SYRINGE, IRRIGATING (NON DENTAL)
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20144629
• Report Number: 2618282-2024-00120
• Device Sequence Number: 4237138
• Product Code: KYW
• UDI-Device Identifier: 50382904085310
• UDI-Public: (01)50382904085310(11)220916(17)270731(10)2222712
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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,Followup
• Report Date (Section B): 11/21/2024

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: 408531
• Device Lot Number: 2222712
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 11/21/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/20/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown