MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 1ML LS SP120

Catalog Number 303172

Device Problems Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

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 that syringe 1ml ls sp120 had foreign matter and scale marking issues.The following information was provided by the initial reporter: this is a report about the following issues of syringe.The customer uses this product for covid vaccination.Syringe needle connectivity issue: the connection between the syringe and the needle is loose.Fm: dirt was found on the product.Scale marking issue: the scale was partially missing/illegible.Molding defect (air bubbles).

Manufacturer Narrative

The following field was updated due to corrected information: b.5.Describe event or problem: it was reported that syringe 1ml ls sp120 had foreign matter and scale marking issues.The following information was provided by the initial reporter: this is a report about the following issues of syringe.The customer uses this product for covid vaccination.Fm: dirt was found on the product.Scale marking issue: the scale was partially missing/illegible.The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 9/7/2021 h.6.Investigation: two syringes received for investigation, defective devices are 1ml syringe with reference 303172 and lot number unknown.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Upon visual inspection of the syringes two defects can be observed.One syringe has black foreign matter embedded in the plunger.This is embedded burnt material from molding process.This defect appeared due to the injection of burnt material generated during molding process.Before the injection machine is restarted up it is purged until the material is acceptable rejecting the first pieces.Injection machines are periodically subjected to maintenance and cleaning program.The second defect observed is the lack of a marking line in the second device provided, the 0,3 line is missing.This defect has been produced because the ink was not correctly transferred to the barrel due to a failure in the patters that transfers the scale or in the flaming system that prepare material for ink penetration previously to ink transference.Marking is legible.Possible root cause of foreign matter is associated with the injection of burnt material.Possible root cause for scale marking issue is associated to a failure in the patterns that transfers the scale.Based on the investigation results, no manufacturing related defects could be identified for connectivity issue, and air bubbles, therefore, a cause for the reported incident could not be determined.

Event Description

It was reported that syringe 1ml ls sp120 had foreign matter and scale marking issues.The following information was provided by the initial reporter: this is a report about the following issues of syringe.The customer uses this product for covid vaccination.Fm: dirt was found on the product.Scale marking issue: the scale was partially missing/illegible.

• Brand Name: SYRINGE 1ML LS SP120
• 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: 12322025
• MDR Text Key: 266680378
• Report Number: 3003152976-2021-00475
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303172
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• 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