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

Catalog Number 302055

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

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

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that foreign particles were found on 2 bd luer-lok¿ syringe plungers.The following information was provided by the initial reporter, translated from (b)(6) to english: "we received a report from one of our customers that particles were found in the 20 ml syringe: item v62.302055 with batch 1912351.Particles were discovered on the syringe plunger during preparation.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/11/2021.H.6.Investigation: sixteen samples and photos received for investigation, two syringes were sent separately from the other 14 provided.All syringes have been visually inspected not finding foreign matter in any of the parts of the syringe.Plungers of all syringes were examined at the microscope (10x) nor finding any foreign matter or particle attached or embedded.A device history review was performed for lot 1912351, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.The assembly station has a de-ionizer and vacuum system used to remove any particles inside the barrel.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.The areas where pieces run in manufacturing area are protected to avoid damage on the product and reduce particles from generating.H3 other text : see h.10.

Event Description

It was reported that foreign particles were found on 2 bd luer-lok¿ syringe plungers.The following information was provided by the initial reporter, translated from dutch to english: "we received a report from one of our customers that particles were found in the 20 ml syringe: item v62.302055 with batch 1912351.Particles were discovered on the syringe plunger during preparation.".

• Brand Name: BD LUER-LOK¿ SYRINGE
• Type of Device: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12827996
• MDR Text Key: 280901873
• Report Number: 3003152976-2021-00765
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302055
• Device Lot Number: 1912351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1