MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB; PISTON SYRINGE

Model Number 305904

Device Problems Failure to Deliver (2338); Material Deformation (2976)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

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 that the syringe 3ml ll w/ndl sftygld 25x5/8 rb experienced difficult plunger movement, and a deformed stopper.The following information was provided by the initial reporter: faulty syringe.When pulling back on the plunger it stopped half way down, writer noticed that the plunger inside the syringe was missing a piece from one of its sides.The external part of the syringe is also dented/squished at the 2 ml mark making it so that you cannot extend the plunger the full length.The packaging, box and remaining syringes did not appear to be damaged.Unexpected or prolonged care? -no level of harm: -no effect.Did not reach patient - detected before use or does not touch person during use.

Event Description

It was reported that the syringe 3ml ll w/ndl sftygld 25x5/8 rb experienced difficult plunger movement, and a deformed stopper.The following information was provided by the initial reporter: faulty syringe.When pulling back on the plunger it stopped half way down, writer noticed that the plunger inside the syringe was missing a piece from one of its sides.The external part of the syringe is also dented/squished at the 2 ml mark making it so that you cannot extend the plunger the full length.The packaging, box and remaining syringes did not appear to be damaged.Unexpected or prolonged care? no.Level of harm: no effect.Did not reach patient - detected before use or does not touch person during use.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-14.H6: investigation summary: it was noticed that the plunger stopped half way, was missing piece from one of its sides, and the external part of the syringe is also dented.To aid in the investigation, one sample in an opened packaging blister and three photos were received for evaluation by our quality team.A visual inspection was performed.The syringe barrel is damaged at the 1.8ml mark.The plunger rod also has one of the ribs damaged.No other defects or imperfections were observed.The three photos provided show the sample received.For this defect, it is likely that a jam occurred during the assembly process resulting in the damage to the syringe.A device history record review was completed for provided material number 305904, lot number 1076335.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the feeding system and conveyor were performed.No catching points of jams were observed.The flow of products was acceptable.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12464805
• MDR Text Key: 271308008
• Report Number: 1911916-2021-00981
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903059042
• UDI-Public: 30382903059042
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305904
• Device Catalogue Number: 305904
• Device Lot Number: 1076335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1