MAUDE Adverse Event Report: BECTON DICKINSON CAP FEMALE LUER LOK S/SU; CONTAINER, LIQUID MEDICATION, GRADUATED

Catalog Number	408531
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 408531; batch number#: 2222712.It was reported by customer that while inspecting prior to use they found black particles in some of the caps.Verbatim#: rcc received a complaint via email.Email(s) attached.While inspecting prior to use they found black particles in some of the caps.
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Additional Manufacturer Narrative
One photo was received for investigation.Through visual inspection, is observed in the photo a white female cap in an open blister and in the top part a dark mark is seen.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 feed of product into the blister pocket.Manufacturing personnel have been notified of this incident to increase awareness of this matter.
Event or Problem Description
No additional information.

• Brand Name: CAP FEMALE LUER LOK S/SU
• Common Device Name: CONTAINER, LIQUID MEDICATION, GRADUATED
• 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: 20038961
• Report Number: 2618282-2024-00115
• Device Sequence Number: 16912830
• 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: NJ
• 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
• Report Date (Section B): 09/19/2024

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: 08/07/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/19/2024
• 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