MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1; PISTON SYRINGE

Catalog Number 305832

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

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

Event Date 09/02/2021

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 when using the syringe flu plus 0.25-1ml var dose 23x1there was foreign matter on device cannula/needle/syringe or any fluid path component.The following information was provided by the initial reporter.The customer stated: "flu syringe foreign matter.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-09-09.H6: investigation summary: a device history record review was completed for provided lot number 2103419.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, a picture and two physical samples without packaging, one sample in a sealed package, and one opened sample were returned for evaluation by our quality engineer team.All of the returned samples were examined and the sample with the needle still in the vial showed a dark piece of material floating in the barrel.After a flush test was performed, the syringe and the filters from each of the ten flushes were checked.The foreign matter was not expelled from the barrel during the flush tests.A portion of this material was removed for fourier-transform infrared (ftir) spectral analysis.The ftir results show that the floating foreign matter was most likely composed of polycarbonate.It has been determined that this foreign particle most likely resulted from powder in the syringe assembly process.Due to friction between plastic racks and the assembly machinery rails, plastic powder can be produced.An accumulation of this powder could end up in the syringe due to static electricity.

Event Description

It was reported when using the syringe flu plus 0.25-1ml var dose 23x1 there was foreign matter on device cannula/needle/syringe or any fluid path component.The following information was provided by the initial reporter.The customer stated: "flu syringe foreign matter.".

• Brand Name: SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1
• 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: 12557480
• MDR Text Key: 274346531
• Report Number: 3002682307-2021-00529
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K091377
• 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: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305832
• Device Lot Number: 2103419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2021
• 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