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

Catalog Number 30773019

Device Problem Volume Accuracy Problem (1675)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter zip: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported syringe 2ml ls 23ga 1-1/4in dn emerald had scale marking issues.The following information was provided by the initial reporter, translated from (b)(6): "after unpacking, it was found that the 2ml syringe had no scale".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 8/12/2021.H.6.Investigation: a device history record review was completed for provided bd material 3077019 and lot number 2011199.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, both pictures and the physical sample were returned for evaluation by our quality engineer team.Through examination of the returned sample, a syringe was observed without any scale markings.The process used to print the scale is called hot stamping.A stamp is heated and used to interpose a special blank printing foil onto the barrel.Through the use of pressure, the printing foil becomes embedded within the barrel wall.It has been determined that this incident resulted from a defective printing foil roll.The foil did not act as expected, causing improper placement between the stamp and the barrel, and therefore resulting in a missing print.H3 other text : see h.10.

Event Description

It was reported syringe 2ml ls 23ga 1-1/4in dn emerald had scale marking issues.The following information was provided by the initial reporter, translated from chinese: "after unpacking, it was found that the 2ml syringe had no scale".

• Brand Name: SYRINGE 2ML LS 23GA 1-1/4IN DN EMERALD
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 12380293
• MDR Text Key: 271934850
• Report Number: 3002682307-2021-00446
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 30773019
• Device Lot Number: 2011199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1