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

Catalog Number 300865

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

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

Event Date 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

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 when using the bd plastipak¿ concentric luer lock syringe, the device experienced foreign matter within the fluid path.The following information was provided by the initial reporter.The customer stated: hematology - cellular therapy laboratory presence of a "lint" of black fibre in the plunger of a 50 ml syringe before opening the blister pack.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 10/8/2021.H6: investigation: one sample received for investigation, 50ll syringe with reference (b)(4) and lot number 2006304.Upon visual inspection, it can be observed there is a black particle on the plunger of the syringe, outside the fluid path.The particle is observed at the microscope (5x) and it can be seen it is green with fibers.A device history review was performed for the reported lot 2006304, 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.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.H3 other text: see h10.

Event Description

It was reported when using the bd plastipak¿ concentric luer lock syringe, the device experienced foreign matter within the fluid path.The following information was provided by the initial reporter.The customer stated: hematology - cellular therapy laboratory.Presence of a "lint" of black fibre in the plunger of a 50 ml syringe before opening the blister pack.

• Brand Name: BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• 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: 12648264
• MDR Text Key: 276937776
• Report Number: 3003152976-2021-00694
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 2006304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• 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