MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 1ML LS SP120; PISTON SYRINGE

Catalog Number 303172

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that 136 syringe 1ml ls sp120 had the syringe and mating component spin out the following information was provided by the initial reporter: according to the customer's report, due to a large amount of silicone oil, such issues as the connection site becoming slimy and the needle easily coming off are occurring at increased frequency.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-07.H6: investigation summary: samples received for investigation, upon visual inspection of the samples, no excessive silicone is noticed in the fluid path.No other defects can be noticed.A device history review was performed for lot 2009096, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Lubricant is employed during the syringe assembly process to lubricate the cylinders in the silicone station.The silicone employed in this product is a medical grade silicone authorized for product use.Silicone content tests are performed during the manufacturing process of each lot number.Results were reviewed for lot 2009096 and found to be within specification.Testing was performed on the samples, results verified amount of silicone was with the required limits.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.Based on the investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that 136 syringe 1ml ls sp120 had the syringe and mating component spin out the following information was provided by the initial reporter: " according to the customer's report, due to a large amount of silicone oil, such issues as the connection site becoming slimy and the needle easily coming off are occurring at increased frequency.".

• Brand Name: SYRINGE 1ML LS SP120
• 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: 12374727
• MDR Text Key: 268454396
• Report Number: 3003152976-2021-00505
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303172
• Device Lot Number: 2009096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• 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