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

Catalog Number 324907

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Skin Tears (2516)

Event Date 11/05/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 while using the bd ultra-fine¿ insulin syringe deep lacerations were left below needle puncture site.Report 2 of 2.The following was received by the initial reporter: consumer reported found 2 syringes that hurt and tore up skin when removed.This caller informed he reuses - each syringe used for 2 injections.Informed caller not to reuse.With reasons.Date of event 11/06/2023 = 1 syringe - awaiting sample.Date of event 11/05/2023 - 1 syringe -discard.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 01dec2024 h.6.Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.H3 other text : see h.10.

Event Description

It was reported that while using the bd ultra-fine¿ insulin syringe deep lacerations were left below needle puncture site.Report 2 of 2.The following was received by the initial reporter: consumer reported found 2 syringes that hurt and tore up skin when removed.This caller informed he reuses - each syringe used for 2 injections.Informed caller not to reuse.With reasons.Date of event 11/06/2023 = 1 syringe - awaiting sample date of event 11/05/2023 - 1 syringe -discard.

• Brand Name: BD ULTRA-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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18234793
• MDR Text Key: 330566845
• Report Number: 1920898-2023-00796
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249077
• UDI-Public: (01)00382903249077
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 324907
• Device Lot Number: 8344507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• 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