MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE 50ML LL INDIA; PISTON SYRINGE

Catalog Number 303288

Device Problem Material Separation (1562)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 during use with bd syringe 50ml ll india the stopper separated from the plunger.There was no patient impact.The following information was provided by the initial reporter: leurlok plastipak 50ml plunger got dislodged from stopper while aspiration.

Manufacturer Narrative

H6: investigation summary: two photos were provided to our quality team for investigation.Through visual inspection, the stopper was verified to be disassembled from the stopper.There is no other visual defect noted within the plunger that could have caused the stopper to separate.A device history review was performed for lot 2301097, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.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, no issues were found related to this incident.It is possible the stopper was partially assembled before use, causing it to fully dislodge during use.Based on the available information and given the device records do not indicate any issues, we cannot identify a definitive root cause at this time.

Event Description

It was reported that during use with bd syringe 50ml ll india the stopper separated from the plunger.There was no patient impact.The following information was provided by the initial reporter: leurlok plastipak 50ml plunger got dislodged from stopper while aspiration.

• Brand Name: BD SYRINGE 50ML LL INDIA
• 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.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17445895
• MDR Text Key: 320257193
• Report Number: 3003152976-2023-00310
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 09/11/2023

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: 303288
• Device Lot Number: 2301097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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