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

Catalog Number 303172

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2105074.Medical device expiration date: 2026-04-30.Device manufacture date: 2021-04-28.Medical device lot #: 2102021.Medical device expiration date: 2026-01-31.Device manufacture date: 2021-02-01.

Event Description

It was reported that 2 syringe 1ml ls sp120 experienced foreign matter in the fluid path.The following information was provided by the initial reporter: syringes show defects.

Event Description

It was reported that 2 syringe 1ml ls sp120 experienced foreign matter in the fluid path.The following information was provided by the initial reporter: syringes show defects.

Manufacturer Narrative

H.6.Investigation: photo received for investigation, upon visual inspection of the pictures provided, in one picture it can be observed there is a syringe with the stopper not correctly assembled, additionally the second photo shows foreign matter inside the syringe.This foreign matter noticed is transparent plastic that is blocking the tip of the syringe.The tip of the syringe is not correctly molded and the foreign matter noticed by customer is a consequence of the incorrect molding of the tip.Possible root cause for foreign matter is associated with the molding process.Possible root cause for jammed stopper is related with a misalignment of plunger-stopper-barrel in the assembly station.Dhr from lot 2102021 was reviewed not finding any annotation or deviation regarding the alleged defect.Dhr from lot 2105074 was reviewed and annotation regarding barrel molding was found in dhr.Cavity nº49 of the mold s-27 was cancelled due to a pin that was taken off during manufacturing of this lot.Pins in molds are used to give a carnation geometry to parts.According to the picture received and the annotation found in the dhr, the root cause of the alleged defect is related to the taken off pin with high probability.If a pin is taken off, the inner geometry of the syringe is not correctly manufactured and the tip of the syringe is not molded properly, leaving additional plastic and blocking the tip.

• 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: 12625451
• MDR Text Key: 276863336
• Report Number: 3003152976-2021-00684
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303172
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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