MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ SYRINGE

Catalog Number 307736

Device Problems Air Leak (1008); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).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 by that the during catheter sampling, the nurse noticed large air intake from the bd emerald¿ syringe.She tries to purge the air and notices that the syringe is split to the side.No exposure of blood or bodily fluids to the healthcare workers.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: sample evaluation we have been provided with the affected sample which presented a crack in the syringe barrel wall, confirming the reported issue.Bhr review we have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qa nor ncmr's.Syringes were packed in machine nº2017 (january 22nd - 24th, 2018).Syringes were assembled in machine, nº4253, and nº4260, in lot #8015768 (january 15th - 22nd, 2018) and in lot #8022709 (january 22nd - 29th, 2018).Research has found no problems, defects or qn related to the reported issue.We have also reviewed the barrel lots #8022727, #8015703, and #7354653 and no problems, defects or qn related to the reported issue were found.Root cause analysis based on our experience and the kind of crack on the syringe, we think that the origin of the problem is caused due to a hard condition of handling or transportation.When a package of syringes is hit hard due to a strong handling, the finger grips of some syringes can damage the wall of the opposite barrel, producing cracks.The packaging material has been tested to resist normal conditions of transportation, and the product is continuously inspected in the process.We must also take into account that plastic material is getting brittle with low temperatures.However, the barrel will only crack if we apply an excessive force on it.Confirmation the returned sample presented the barrel wall of the syringe damaged.We could confirm the reported issue.Capa determination based on an evaluation of severity and occurrence it was determined that no corrective action is required at this time.

• Brand Name: BD EMERALD¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7530205
• MDR Text Key: 109007436
• Report Number: 3002682307-2018-00124
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 307736
• Device Lot Number: 1801266
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other