MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50ML LL; SYRINGE, PISTON

Catalog Number 300865

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

Filled something into these syringes and the liquid ran straight out the bottom again.

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f26 ¿ no health consequences or impact.Device problem code: a050401 - fluid/blood leak.

Manufacturer Narrative

(b)(4) follow up mdr for device evaluation: one photo and one physical sample were provided to our quality team for investigation.Through visual inspection, a leakage past the stopper ribs was observed.Upon further evaluation, no damage or defects were observed that could have contributed to the reported leak and the stopper was properly assembled.A device history review was performed for the reported lot 2305104, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.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, including leakage testing.The returned product underwent these evaluations and no issues were identified.Based on our investigation and given the device records did not reveal any quality issues, we cannot identify a definitive root cause at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

Event Description

Filled something into these syringes and the liquid ran straight out the bottom again could you please reach out to the customer and request of there was any damage observed on the device.= no damage.Could you please confirm what substance was leaking? = iodine.Could you please confirm what was the patient impact? = no.We would like to ask you to confirm if any samples are available for investigation.If yes, could you please specify if the samples are: = unused (before use).

• Brand Name: SYRINGE 50ML LL
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18211840
• MDR Text Key: 329593989
• Report Number: 3003152976-2023-00513
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903008650
• UDI-Public: (01)00382903008650
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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: Health Professional
• Device Catalogue Number: 300865
• Device Lot Number: 2305104
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1