MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE NON STERILE 50ML LL

Catalog Number 300223

Device Problem Leak/Splash (1354)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2103502, medical device expiration date: 2026-02-28, device manufacture date: 2021-03-23.Medical device lot #: 2104120, medical device expiration date: 2026-03-31, device manufacture date: 2021-04-26.Investigation summary: samples and photos received for investigation.Upon observation, all syringes received present defects in the luer lock and tip pf the syringe.One syringe has the luer lock detached.Five syringes present the tip completely detached, and two devices have the thread damaged.The eight syringes sent by customer came without lot number identification, so we cannot associate to each device one of the two lot numbers given.A device history review was performed for reported lot 2103502 and 2104120, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported 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.Possible root cause can be related with the damaged pins in the mold where the parts were manufactured.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.No corrective action is required at this time.

Event Description

It was reported that syringe non sterile 50ml ll was damaged.This occurred on 7200 occasions.The following information was provided by the initial reporter: according to our analysis, it is an injection molding defect on the luer cone.To us, it looks like the cone is injected twice.

• Brand Name: SYRINGE NON STERILE 50ML LL
• Type of Device: 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: 12576489
• MDR Text Key: 274782329
• Report Number: 3003152976-2021-00659
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300223
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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