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

Catalog Number 300865

Device Problems Break (1069); Leak/Splash (1354); Free or Unrestricted Flow (2945)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

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 was damaged and had air leakage.The following information was provided by the initial reporter: return of blood present in the syringe from the central line, while it was in place in the syringe pump.Cracked syringe? air leak? syringe changed immediately when the nurse enters the room.13/apr/2021 - update according to the reporting department, i can confirm that there were no adverse effects on the patient, and the product that was inside the syringe was not cytotoxic.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/10/2021.H.6.Investigation: one sample and two photos were provided to our quality team for investigation.Through visual inspection, a leakage along the plunger was observed.Upon inspection the syringe, there is no damage or defect within the plunger, the stopper is properly assembled on to plunger, however, the barrel is observed to be damaged.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.As a lot number was unknown for this incident, a device history record review could not be completed.It is possible the damage occurred due to the syringe jamming in the manufacturing equipment.Without a lot code to review device history records, we are not able to properly identify where the damage originated therefore a definitive root cause cannot be determined.

Event Description

It was reported that syringe 50ml ll was damaged and had air leakage.The following information was provided by the initial reporter: return of blood present in the syringe from the central line, while it was in place in the syringe pump.Cracked syringe? air leak? syringe changed immediately when the nurse enters the room.On 13/apr/2021 - update: according to the reporting department, i can confirm that there were no adverse effects on the patient, and the product that was inside the syringe was not cytotoxic.

• 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
• MDR Report Key: 11781056
• MDR Text Key: 253482278
• Report Number: 3003152976-2021-00251
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• 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: 05/10/2021
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1