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

Catalog Number 328821

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd ultra-fine¿ ii short needle insulin syringe the needle broke.The following information was provided by the initial reporter: after the injection, the needle broke and remained embedded in her abdomen.Feeling a persistent sensation fo the needle still being inside, she visited nearby clinic for an ultrasound, but the needle wasn't detected.But the sensation persisted, so patient went to a secondary hospital's emergency room where x-rays and ct scans were performed, but the needle couldn't be found.But patient still feels that the needle is inside her abdomen.Patient is a t1d patient who has been taking insulin injections for over 10 years, and patient mentioned that one of her eyes has poor vision, and she's experienced bent needles during injections before.

Event Description

It was reported while using bd ultra-fine¿ ii short needle insulin syringe the needle broke.The following information was provided by the initial reporter: after the injection, the needle broke and remained embedded in her abdomen.Feeling a persistent sensation fo the needle still being inside, hse visited nearby clinic for an ultrasound, but the needlt wasn't detected.But the sensation persisted, so patient went to a secondary hospital's emergency room where x-rays and ct scans were performed, but the needle couldn't be found.But patient still feels that the needle is inside her abdomen.Patient is a t1d patient who has been taking insulin injections for over 10 years, and patient mentioned that one of her eyes has poor vision, and she's experienced bent needles during injections before.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 05-oct-2023.H6: 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 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.

• Brand Name: BD ULTRA-FINE¿ II SHORT NEEDLE 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17786501
• MDR Text Key: 323893624
• Report Number: 1920898-2023-00640
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 328821
• Device Lot Number: 9042883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2019
• 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
• Patient Outcome(s): Required Intervention