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

Catalog Number 300865

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that syringe 50ml ll had cracks and leaked.The following information was provided by the initial reporter: leakage observed when activating the syringe pump.Event#1.2 crack lines are visible on the body of the syringe.Event#2.No consequences, not used on a patient.Sample contaminated with ketamine.

Manufacturer Narrative

H6: investigation summary one sample received for investigation.Upon visual inspection of the samples received, liquid passed through the stopper is observed.Stopper is correctly assembled and no molding defect in any of the parts can be observed.When barrel is examined, damage between numbers 30 and 40 of the scale can be observed.This hit, is produced during assembly process and may deform the shape of the barrel leading to the leakage experienced by customer.Further testing was conducted on samples, no sign of leakage occurred.Possible root cause for damaged barrel is associated with the manufacturing process.When there is damage in the barrel, the part can be deformed causing a mis adjustment between the stopper, barrel and plunger and leading the leakage.Areas where pieces are transported in manufacturing area are protected to avoid damage on the product.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.H3 other text : see h10.

Event Description

It was reported that syringe 50ml ll had cracks and leaked.The following information was provided by the initial reporter: leakage observed when activating the syringe pump.Event#1.2 crack lines are visible on the body of the syringe.Event#2.No consequences, not used on a patient.Sample contaminated with ketamine.

• Brand Name: SYRINGE 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: 12515615
• MDR Text Key: 273144638
• Report Number: 3003152976-2021-00626
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• 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