MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1ML 31GA 6MM 10 BAG 500 SLA

Catalog Number 324918

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 12/24/2020

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe 1ml 31ga 6mm 10 bag 500 sla needle broke.The following information was provided by the initial reporter: "i have a(b)(6) year-old son who has been using growth hormone (somatropin) for about 2 and a half years.I have always used bd syringes and had never had a problem.On 12/24 my wife went to apply the hormone and needle fractured.I would like some information about this event, since it was the first time this happened.We were very concerned about what happened.".

Manufacturer Narrative

The following fields were updated due to corrected information: h1: type of reportable events: serious injury.H6: investigation summary: no samples were returned therefore the investigation was performed based on the photos provided.Nine photos of 1ml bd insulin syringes from lot# 9091596 were provided.The customer reported that the needle fragment remained inserted into the skin after the needle was removed.The photos were reviewed, and it was observed that 1 syringe exhibited a broken cannula.The broken cannula could have caused harm to the user.It is difficult to determine the root cause for the issue based on the photos alone.A review of the device history record was completed for batch# 9091596.All inspections were performed per the applicable operations qc specifications.There were three (3) notifications noted that did not pertain to the complaint.Bd was able to confirm the customer¿s indicated failure based on the photos received (cannula broken).Root cause cannot be determined based on the photos provided alone.H3 other text : see h10.

Event Description

It was reported that syringe 1ml 31ga 6mm 10 bag 500 sla needle broke.The following information was provided by the initial reporter: "i have a 4-year-old son who has been using growth hormone (somatropin) for about 2 and a half years.I have always used bd syringes and had never had a problem.On (b)(6) my wife went to apply the hormone and needle fractured.I would like some information about this event, since it was the first time this happened.We were very concerned about what happened.".

• Brand Name: SYRINGE 1ML 31GA 6MM 10 BAG 500 SLA
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11203977
• MDR Text Key: 251657891
• Report Number: 1920898-2021-00091
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324918
• Device Lot Number: 9091596
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR