MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ 5 ML SYRINGE

Catalog Number 301942

Device Problems Air Leak (1008); Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

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 during use of the bd¿ syringe there was an issue with air bubbles/air leakage.It was stated the ¿nurse found a lot of air leaked into the syringe barrel when withdrawing blood.No adverse impact to patient.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: sample evaluation/ we have been provided with the affected samples.A leakage through the plunger rod was observed in this provided sample.We could not determinate the exactly root cause due to the presence of dry blood inside the syringes.The samples were not decontaminated.Bhr review: we have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Syringes were packed in machine nº2022 (july 17 - 19th, 2017).Syringes were assembled in machine, nº4255, nº4254, nº4237, and nº4220, in lot #7187047 (july 6 - 17th, 2017) and in lot #7198306 (july 17 - 24th, 2017).Research has found no problems, defects or qn related to the reported issue.We have also reviewed the barrels lots #7187011, #7198282, and #7160133 and no problems, defects or qn related to the reported issue were found.We have also reviewed the plunger lots #7187015, #7198288, and #7160137 and no problems, defects or qn related to the reported issue were found.Root cause analysis: we conclude that the cause of the problem could be produced as a consequence of a damage in the plunger lip.This could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.Confirmation: the provided samples presented the reported issue.We could confirm the reported issue.Capa determination: based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time.

• Brand Name: BD¿ 5 ML SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7389769
• MDR Text Key: 104258259
• Report Number: 3002682307-2018-00097
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 301942
• Device Lot Number: 1707136
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other