MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 28GA 1/2IN BLS

Catalog Number 329461

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

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.(b)(4).

Event Description

It was reported that the syringe 0.5ml 28ga 1/2in bls experienced foreign matter on the device cannula/in the fluid path.The following information was provided by the initial reporter: material no.329461.Batch no.0132264.Bd canada received a phone call from an animal hospital.A client has been using item 329461.Lot 0132264.Says when the client pushes forward on the syringe prior to use, a drop of liquid comes out of it.This is happening every 4th or 6th syringe, and customer is wondering if this is normal or what may be causing this to happen.

Event Description

It was reported that the syringe 0.5ml 28ga 1/2in bls experienced foreign matter on the device cannula/in the fluid path.The following information was provided by the initial reporter: material no.329461; batch no.0132264.Bd canada received a phone call from an animal hospital.A client has been using item 329461 lot 0132264.Says when the client pushes forward on the syringe prior to use, a drop of liquid comes out of it.This is happening every 4th or 6th syringe, and customer is wondering if this is normal or what may be causing this to happen.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-03-15.H6: investigation summary: customer returned (10) 1/2cc, 12.7mm, 28g syringes in sealed blister packs from lot # 0132264.Customer states that a drop of liquid comes out of the syringe when plunger is depressed.All returned syringes were tested and 2 out of 10 returned syringes exhibited a clear droplet of material coming out the barrel when the plunger rod was fully depressed.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely silicone.A review of the device history record was completed for batch# 0132264.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.There was one (1) notification noted for excessive silicone.

• Brand Name: SYRINGE 0.5ML 28GA 1/2IN BLS
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11382282
• MDR Text Key: 242284071
• Report Number: 1920898-2021-00226
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• 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: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 329461
• Device Lot Number: 0132264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1