MAUDE Adverse Event Report: BECTON DICKINSON CAP FEMALE LUER LOK S/SU; CAP, DEVICE DISINFECTANT

Catalog Number 408531

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f27 ¿ no patient involvement.Device problem code: a180104 - device contamination with chemical or other material.Lot 2075464 manufactured on: 2022-04-22.Lot 2159531 manufactured on: 2022-07-25.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.

Event Description

Material#:408531 batch#: 2075464, 2159531.It was reported by customer that loose particles and debris were found in the unopened syringe caps.Debris were found on the inner part of unopened syringe caps , particles were embedded between the back and plastic barriers.Verbatim: complaint received via email.Email(s) attached.Loose particles and debris were found in the unopened syringe caps.Debris were found on the inner part of unopened syringe caps , particles were embedded between the back and plastic barriers.

Manufacturer Narrative

Sixteen samples for batch 2159531 and photos received by our quality team for investigation.Through visual inspection, small round white foreign matter is observed located inside the blister packaging at sealing area.Foreign matter appears to be part of the cap female material.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.Based on the teams investigation, possible root cause is associated with personnel 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 Description

Material#:408531; batch#: 2075464, 2159531.Verbatim: complaint received via email.Email(s) attached.Loose particles and debris were found in the unopened syringe caps.Debris were found on the inner part of unopened syringe caps, particles were embedded between the back and plastic barriers.

• Brand Name: CAP FEMALE LUER LOK S/SU
• Type of Device: CAP, DEVICE DISINFECTANT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17956729
• MDR Text Key: 325925258
• Report Number: 2618282-2023-00086
• Device Sequence Number: 1
• Product Code: KYW
• UDI-Device Identifier: 50382904085310
• UDI-Public: (01)50382904085310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 408531
• Device Lot Number: 2075464
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1