MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT II 20 ML SYRINGE; PISTON SYRINGE

Catalog Number 300296

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2020

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.(b)(4).

Event Description

It was reported that during use tip cap is broken and is in tubing with a bd discardit¿ ii 20 ml syringe.The following information was provided by the initial reporter, translated from french to english: use of this syringe, connected to 1 needle for preparation directed delivery at 10:30 am, needle discarded at the end of the gesture and syringe kept cool in accordance with the protocol.Syringe resumed at 10:45 am and used at 11:19 am for vili injection over 1 minute, in theory ms impossible because the syringe tip is broken in the tubing.Impossible to inject the directed delivery: increased risk of hemorrhage from the delivery (transfer to another syringe and product injected at 11:21 a.M.).Delivery without difficulty, no bleeding.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/12/2020.H.6.Investigation: a device history record review was performed for provided lot number 1912164.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all inspection were found to be within specification.To aid in the investigation of this issue, one physical sample was returned for evaluation by our quality engineer team.Through examination of the returned sample, the tip component was observed broken.The material used to manufacture the discard it syringes has been selected and tested to resist normal conditions of use.The assembly machines have a detection system in place to automatically detect and reject any defective product.It is possible that a minor, undetectable damage occurred to the syringe during the manufacturing process, which then caused the syringe to break during use.

Event Description

It was reported that during use tip cap is broken and is in tubing with a bd discard it¿ ii 20 ml syringe.The following information was provided by the initial reporter, translated from french to english: use of this syringe, connected to 1 needle for preparation directed delivery at 10:30 am, needle discarded at the end of the gesture and syringe kept cool in accordance with the protocol.Syringe resumed at 10:45 am and used at 11:19 am for vili injection over 1 minute, in theory ms impossible because the syringe tip is broken in the tubing.Impossible to inject the directed delivery: increased risk of hemorrhage from the delivery (transfer to another syringe and product injected at 11:21 a.M.).Delivery without difficulty, no bleeding.

• Brand Name: BD DISCARDIT II 20 ML SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 10182002
• MDR Text Key: 203304894
• Report Number: 3002682307-2020-00192
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300296
• Device Lot Number: 1912164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2020
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other