MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 10ML LS EMERALD

Catalog Number 307736

Device Problem Mechanical Problem (1384)

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

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

(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 that during use of the syringe 10ml ls emerald it is difficult to draw, hard to get the vacuum.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: 10 ml emerald: difficult to draw, hard to get the vacuum before 5 ml and 10 ml plastipak: was great.

Manufacturer Narrative

Investigation: bd has been provided with samples for catalog 307736 lot 1901250 to investigate for this record.The evaluation of the samples did not present any defect.The sliding and performance of the syringe was found correct in all cases.As a result, bd was unable to verify the reported issue.There could be a difference between emerald and other 3pc syringes like bd plastipak related to the force required to initially move the plunger (breakout force) and force necessary to maintain an even flow of fluid out of the syringe (sustaining force).The improved gliding performance in emerald vs plastipak may reduce hand fatigue but could be attributing to the change in ¿feel¿ between emerald syringes and other devices.Users who are unfamiliar with the improved gliding force of emerald may note a sudden bolus of fluid movement prior to stabilizing in various procedures including blood collection and small volume blood sampling procedures.Dhr showed no indication of the alleged defect.

Event Description

It was reported that during use of the syringe 10ml ls emerald it is difficult to draw, hard to get the vacuum.Foreign complaint the following information was provided by the initial reporter, translated from german to english: 10 ml emerald: difficult to draw, hard to get the vacuum before 5 ml and 10 ml plastipak: was great.

• Brand Name: SYRINGE 10ML LS EMERALD
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8560515
• MDR Text Key: 145776195
• Report Number: 3002682307-2019-00275
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 307736
• Device Lot Number: 1901250
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other