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

Catalog Number 324918

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/18/2020

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to calculate a placeholder date for this field.(b)(6).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 bd ultra-fine¿ insulin syringe needle broke off inside the patient's stomach near the navel during use.As a result, the consumer went to the emergency room, where an incision was made and the broken needle removed.The following information was provided by the initial reporter, translated from (b)(6) to english: "when injecting insulin in his father, the needle broke and stayed in the patient's belly, close to the navel.He said his father has been using the brand for 25 years and it never happened to him.There was no red or purple at the application site, the patient feels pain due to the needle being inside his belly.Customer took his father to the emergency room." "additional information: the customer informed by telephone that a small incision was made at the site and the needle was removed, and the patient is not using any type of medication, only a tape and he is doing well.".

Event Description

It was reported that the bd ultra-fine¿ insulin syringe needle broke off inside the patient's stomach near the navel during use.As a result, the consumer went to the emergency room, where an incision was made and the broken needle removed.The following information was provided by the initial reporter, translated from portuguese to english: "when injecting insulin in his father, the needle broke and stayed in the patient's belly, close to the navel.He said his father has been using the brand for 25 years and it never happened to him.There was no red or purple at the application site, the patient feels pain due to the needle being inside his belly.Customer took his father to the emergency room." "additional information: the customer informed by telephone that a small incision was made at the site and the needle was removed, and the patient is not using any type of medication, only a tape and he is doing well.".

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 9077774.All inspections were performed per the applicable operations qc specifications.There were seven (7) notifications [200815574, 200815424, 200815487, 200815149, 200815488, 200814527, 200814138] noted that did not pertain to the complaint.H3 other text : see h.10.

• 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
• MDR Report Key: 10129815
• MDR Text Key: 195756962
• Report Number: 1920898-2020-00630
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 324918
• Device Lot Number: 9077774
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR