MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY; PISTON SYRINGE

Catalog Number 309680

Device Problem Contamination (1120)

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

Event Date 12/12/2022

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 that an unspecified number of bd luer-lok¿ syringe bulk sterile pharmacy convenience trays had issues with foreign matter in the syringes.The following information was provided by the initial reporter: "we have encountered the following issues with the most recent lot of 50ml syringes.Black dots ¿ not removal.White molding issue ¿ top of syringe.Cardboard particle that was inside syringe (since fell out)".

Event Description

It was reported that an unspecified number of bd luer-lok¿ syringe bulk sterile pharmacy convenience trays had issues with foreign matter in the syringes.The following information was provided by the initial reporter: "we have encountered the following issues with the most recent lot of 50ml syringes.Black dots ¿ not removal; white molding issue ¿ top of syringe; cardboard particle that was inside syringe (since fell out).".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 20-dec-2022.H6: investigation summary: it was reported there was foreign matter in the syringe.To aid in the investigation five samples with no packaging blisters were received for evaluation by our quality team.A visual inspection was performed with 10x magnification.Three samples have embedded degraded resin and the other two samples have no defects or imperfections.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.Fourier-transform infrared spectroscopy (ftir) analysis was performed in an attempt to identify the particle¿s composition.The results resulted in a low percent match and therefore are inconclusive.A device history record review was completed for provided material number 309680, lot 2154639.The review revealed there were no internal rejects related to the reported issue by the customer.According to the quality records, all the inspections of the sampling plan met the acceptance criteria.Additional device histories were reviewed for each batch of syringes used in the manufacturing of this batch and there was no documentation for this type of defect during the entire production run.The frequency of inspections were increased to mitigate the embedded degraded resin escapes.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16079390
• MDR Text Key: 308475048
• Report Number: 9610847-2022-00507
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309680
• Device Lot Number: 2154639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2022
• 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