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

Catalog Number 301229

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/29/2021

Event Type  malfunction  

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 Description

It was reported that the bd plastipak¿ luer-lok¿ syringe plunger was damaged and excess silicone oil leaked past it.The following information was provided by the initial reporter, translated from german to english: "our pharmacy has informed us that the silicone oil has leaked from the plunger of a syringe and the plunger itself was damaged".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for evaluation: yes.D10: returned to manufacturer on: 2021-08-30.H6: investigation summary: one sample received for investigation, upon visual inspection it can be observed the plunger is broken.No other damage is detected along the syringe.Additionally, white substance seen is polypropylene dust that entered the syringe.When polypropylene dust falls into the syringe, this substance is formed with the lubricant employed during assembly.Quantification of silicone performed meet specification.A device history review was performed for lot 2101006, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Possible root cause of foreign matter noticed by customer is the entrance of polypropylene particles inside the syringe.Possible root cause is related with a hit during transport or manufacturing.Damaged plunger can be a result during manufacturing process.Areas where pieces are transported in manufacturing area are protected to avoid damage on the product.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.

Event Description

It was reported that the bd plastipak¿ luer-lok¿ syringe plunger was damaged and excess silicone oil leaked past it.The following information was provided by the initial reporter, translated from german to english: "our pharmacy has informed us that the silicone oil has leaked from the plunger of a syringe and the plunger itself was damaged".

• Brand Name: BD PLASTIPAK LUER-LOK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12379002
• MDR Text Key: 268523567
• Report Number: 3003152976-2021-00511
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

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
• Device Operator: Other
• Device Catalogue Number: 301229
• Device Lot Number: 2101006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1