MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINENEEDLE; PISTON SYRINGE

Catalog Number 328290

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 a needle break occurred during use with a bd insulin syringes with bd ultra-fine¿needle.The following information was provided by the initial reporter, "the patient stated that when she pulled the syringe the needle was broken in the stomach.Pt went to er, they did x-ray and ultrasound.They were not able to locate the needle.Surgeon said not to cut the patient because the needle would cause infection and at that time we will be able to locate it.She is not taking any antibiotics.If infection appears later, doctor will address it.".

Event Description

It was reported that a needle break occurred during use with a bd insulin syringes with bd ultra-fine¿needle.The following information was provided by the initial reporter, "the patient stated that when she pulled the syringe the needle was broken in the stomach.Pt went to er, they did x-ray and ultrasound.They were not able to locate the needle.Surgeon said not to cut the patient because the needle would cause infection and at that time we will be able to locate it.She is not taking any antibiotics.If infection appears later, doctor will address it.".

Manufacturer Narrative

H.6.Investigation summary: no samples (including photos) were returned as of 3 january 2020 therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 9035759.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications (b)(4) noted that did not pertain to the complaint.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: BD INSULIN SYRINGES WITH BD ULTRA-FINENEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9491708
• MDR Text Key: 174844286
• Report Number: 1920898-2019-01441
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903282906
• UDI-Public: 00382903282906
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 328290
• Device Lot Number: 9035759
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention