MAUDE Adverse Event Report: BECTON DICKINSON BD QS SYRINGE LS; PISTON SYRINGE

Catalog Number 510005

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2022

Event Type  malfunction  

Event Description

It was reported that bd qs syringe ls had misaligned scale markings.The following information was provided by the initial reporter: "problem with graduation of 1ml syringes.Graduation is diagonal on multiple syringes".

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that bd qs syringe ls had misaligned scale markings.The following information was provided by the initial reporter: " problem with graduation of 1ml syringes.Graduation is diagonal on multiple syringes".

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval?: yes.Returned to manufacturer on: 12-may-2022.Investigation: a device history review was conducted for lot number 2021095.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally a sample was submitted to aid in our investigation.Unfortunately due to the current customs enforcement in china, the device could not be returned to the manufacturing facility for review.In lieu of the physical device, photographs were taken and submitted to the engineering team.Using the photograph our engineers were able to confirm that the printing on the syringe was slanted, but the returned unit lacked the needle component which prevent their investigation in to this non-conformance.Based on these images our engineers were able to determine that the most likely root cause for this event is related to a misorientation of the syringe during the printing process.

• Brand Name: BD QS SYRINGE LS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14138044
• MDR Text Key: 289511426
• Report Number: 2243072-2022-00496
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 510005
• Device Lot Number: 2021095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: No
• 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