MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	309572
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd luer-lok had foreign matter.The following information was provided by the initial reporter: "a client of ours has received product with a white film coating on it." item # 309572.Lot ¿ 2168983.Exp ¿ 05/31/2027.Additional information received by customer on 02/16/2024: "the white film was on the needle.See the attached image.".
Additional Manufacturer Narrative
Two photos of a 3ml luer-lock syringe with 22x1" needle lot 2168983 were received and evaluated.One image shows the lot number and expiration date of the top web slip.The next images show a loose needle with the shield removed and an unknown white substance larger than level 4 on the cannula.The condition observed is non-conforming per product specification.Potential root cause for foreign matter defect is associated with the needle supplier¿s manufacturing process.The photos will be forwarded to the needle supplier for further evaluation and investigation.A device history record review was completed for provided lot number 2168983 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
Material#: 309572; batch#: 2168983.It was reported by customer that a client of ours has received product with a white film coating on it.Verbatim: rcc received a complaint via email.Email(s) attached.A client of ours has received product with a white film coating on it.Item # 309572; lot ¿ 2168983; exp ¿ 05/31/2027.

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18742226
• Report Number: 1213809-2024-00099
• Device Sequence Number: 7229061
• Product Code: FMF
• UDI-Device Identifier: 30382903095729
• UDI-Public: (01)30382903095729
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: Other
• Device Catalogue Number: 309572
• Device Lot Number: 2168983
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown