MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 50ML LL CONVENIENCE TRAY EUROPE

Catalog Number 302238

Device Problems Break (1069); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/04/2021

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 #: 2101073.Medical device expiration date: 2025-12-31.Device manufacture date: 2021-01-15.Medical device lot #: 2103099.Medical device expiration date: 2026-02-28.Device manufacture date: 2021-03-24.Medical device lot #: 2102092.Medical device expiration date: 2026-01-31.Device manufacture date: 2021-02-25.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 when using the syringe 50ml ll convenience tray europe there was a damaged/deformed product - device is operable and foreign matter in the syringe or any fluid path component.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "when opening the 50 ml plastipack convenience pack it is noted that the syringes appear battered and cloudy.".

Event Description

It was reported when using the syringe 50ml ll convenience tray europe there was a damaged/deformed product - device is operable and foreign matter in the syringe or any fluid path component.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "when opening the 50 ml plastipack convenience pack it is noted that the syringes appear battered and cloudy.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-21.H6: investigation summary one convenience pack reference 302238 and lot number 2101073 received for investigation.Lots 2103099 and 2102092 were also claimed but no samples are available.Upon visual inspection of the syringes, it can be observed the material is transparent and correctly molded.No hits in the barrel can be observed.Damage in the flange, near the bottom of the syringe can be seen.In this part of the syringe there is a circumference around the barrel caused by the marking machine, when the syringe is positioned to stamp the scale.This process, can leave a light mark in the barrel that can be related with the defect described by customer.A device history review was performed and found no non-conformances associated with this issue during the production of lots 2101073, 2103099 and 2102092 all product was manufactured according to specification.Possible root cause is associated with the marking process.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.

• Brand Name: SYRINGE 50ML LL CONVENIENCE TRAY EUROPE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12416377
• MDR Text Key: 271913918
• Report Number: 3003152976-2021-00542
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302238
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• 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