MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICRO-FINE¿+ INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 324893

Device Problem Partial Blockage (1065)

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

Event Date 04/13/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that an unspecified number of bd micro-fine¿+ insulin syringes experienced difficult plunger movement.The following information was provided by the initial reporter: when starting to inject the medication, more force was needed than usual with plunger.The solution came out through the needle very slowly (as drops) and sometimes stopped.

Event Description

It was reported that an unspecified number of bd micro-fine¿+ insulin syringes experienced difficult plunger movement.The following information was provided by the initial reporter: when starting to inject the medication, more force was needed than usual with plunger.The solution came out through the needle very slowly (as drops) and sometimes stopped.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 9196599.D4: medical device expiration date: 30-sep2024.D9: device available for eval yes.D9: returned to manufacturer on: 19-may-2022.H4: device manufacture date: 15-jul-2019.H6: investigation summary: customer returned (3) loose 0.5ml bd insulin syringes, and (143) sealed 0.5ml bd insulin syringes from lot# 9196599.The customer reported that more force was needed than usual to move the plunger, and difficulty administering the accurate dose of medication.The 3 loose syringes were examined, then tested for plunger rod movement and flow: all 3 syringes were unable to draw properly.A wire test was then performed on these 3 samples: the wire was able to pass through the cannula of both syringes, and it was observed that a small, clear residue was at the tip of the wire after being through the cannulas.Under the microscope the residue from the 3 cannulas was identified as residual silicone from the manufacturing process.The dislodged residue could not be extracted from the samples for ftir analysis.After performing the wire test, all 3 syringes were able to draw and expel properly, and no difficulty moving the plunger rods was observed.30 out of the 143 samples from lot# 9196599 were tested for plunger rod movement and flow, and all 30 were able to draw and expel properly.No difficulty moving the plunger rods was observed.A review of the device history record was completed for batch # 9196599 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Embecta was not able to duplicate or confirm the customer¿s indicated failure difficulty moving the plunger rod.H3 other text : see h10.

• Brand Name: BD MICRO-FINE¿+ INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14278867
• MDR Text Key: 291384038
• Report Number: 1920898-2022-00308
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 324893
• Device Lot Number: 9196599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• 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