MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGE; PISTON SYRINGE

Catalog Number	300613
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that excessive amounts of barium, potassium, and zinc were found in 2 bd plastipak¿ syringes.The following information was provided by the initial reporter: "we have received x2 product 12044717 lot2211058 on bl3173997230.After testing it turns out that the product cannot be used due to the presence of too much barium, potassium and zinc.".
Additional Manufacturer Narrative
H.6.Investigation summary: no samples or photos received by our quality team for evaluation.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.Ten retained samples from the same lot were evaluated, no foreign matter can be seen out or inside the syringes.Syringes are examined at the microscope (10x) not finding any particle.Raw material is received with a quality certificate ensuring the material provided is safe and adequate for medical use.Upon inspection of the certificate provided by customer showing results of chemical composition, iso 17294 is referenced.This iso specifies a method for determination of chemicals in water.This does not mean the chemicals found came from the medical device since the assay is for water.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign 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.H3 other text : see h10.
Event or Problem Description
It was reported that excessive amounts of barium, potassium, and zinc were found in 2 bd plastipak¿ syringes.The following information was provided by the initial reporter: "we have received x2 product 12044717 lot2211058 on bl3173997230.After testing it turns out that the product cannot be used due to the presence of too much barium, potassium and zinc.".

• Brand Name: BD PLASTIPAK¿ SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16475888
• Report Number: 3003152976-2023-00040
• Device Sequence Number: 3150339
• Product Code: FMF
• UDI-Device Identifier: 00382903006137
• UDI-Public: 00382903006137
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: 300613
• Device Lot Number: 2211058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown