MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 2ML LS 23X1-1/4 DN EMERALD

Catalog Number 307730

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

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

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1607240.Medical device expiration date: 2021-06-30.Device manufacture date: 2016-07-21.Medical device lot #: 1609126.Medical device expiration date: 2021-08-31.Device manufacture date: 2016-08-31.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 the syringe 2ml ls 23x1-1/4 dn emerald experienced difficult plunger movement.The following information was provided by the initial reporter: the product was very poor, such that when the filled medicine is pushed (injecting) it needs a lot of energy to push, ie it stuck upon pushing, it's not softly pushed as normal syringes.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-22.H6: investigation summary: a device history record review was completed for provided lot numbers 1607240 and 1609126.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, twenty-two reference samples were returned for evaluation by our quality engineer team.The samples were inspected and none of the samples revealed any functional issues.The syringes met the production specifications and recommended values.On the other hand, the medication used or the method used (high temperatures, pressures, several uses, etc.) can affect the sliding properties of the syringe.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.

Event Description

It was reported that the syringe 2ml ls 23x1-1/4 dn emerald experienced difficult plunger movement.The following information was provided by the initial reporter: the product was very poor, such that when the filled medicine is pushed (injecting) it needs a lot of energy to push, ie it stuck upon pushing, it's not softly pushed as normal syringes.

• Brand Name: SYRINGE 2ML LS 23X1-1/4 DN EMERALD
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12555340
• MDR Text Key: 274347237
• Report Number: 3002682307-2021-00527
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 307730
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1