MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 30GA 8MM 10BAG 500 L AMR; PISTON SYRINGE

Catalog Number 328328

Device Problems Break (1069); Leak/Splash (1354); Defective Device (2588); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported that a syringe 1.0ml 30ga 8mm 10bag 500 l amr contributed to a needlestick injury, separated from the hub, broke at the cannula, and was found to be damaged during use.The following was reported by the initial reporter: "after the application of insulin, the caregiver suffer a needle stick in her hand, and it damaged the syringe.Daily, the caregiver used to take the syringe, remove the safety cover, and give it to the patient apply in herself.After the application, at the discarding moment, she suffered a needle stick, the needle broke in her hand, and separated from the syringe.There was medical intervention required to remove the needle, and stitches at the local.The event occurred on (b)(6) 2020; patient applies insulin 3 times a day and performs the application rotation.___ (add info added on 05.Apr.2021): the caregiver's mother used insulin for more than 15 years, and always used bd.The patient suffered lost of sight but had no other limiting condition and was lucid.She had hired caregivers assisting her, but she continuously kept applying insulin by herself 3 times per day and never had problems.The patient used to receive the syringe, applied in herself, and performed the local rotation with assistance of her son.On (b)(6) 2020, one hired caregiver suffered an accident when, suddenly, got an used needle stick in her hand, and the needle released from the syringe and got stuck, leading her to need a medical intervention to remove it.The hired caregiver took the syringe in her right hand and injured her left hand, but it's unknown if the needle broke or separated from hub.It was usual for the caregiver to observe needles bending, but he has never seen a needle hub separation.The caregiver (patient's son) is concerned about a litigation, being sued, due to the accident, due to the needle hub separation/needle break, and he needs a backing regarding the product releasing specifications and quality control.He highlights he would like to receive information such as: the strength required to pull the needle and cause a needle hub separates, and the strength required to break a needle; he wants to eliminate the possibility of the needle had actually separated from hub; and he wants to prove that the needle does not release from hub neither breaks as easy as the hired caregiver reports.He looks for the quality standards, and product releasing criteria, so he can protect himself and get covered under a litigation/sue from the injured caregiver.A possible batch affected could be the 0027924, but it's impossible to be sure since his mother, unfortunately, has passed away.Due to the same fact, the caregiver doesn't want the product replacement.".

Event Description

It was reported that a syringe 1.0ml 30ga 8mm 10bag 500 l amr contributed to a needlestick injury, separated from the hub, broke at the cannula, and was found to be damaged during use.The following was reported by the initial reporter: "after the application of insulin, the caregiver suffer a needle stick in her hand, and it damaged the syringe.Daily, the caregiver used to take the syringe, remove the safety cover, and give it to the patient apply in herself.After the application, at the discarding moment, she suffered a needle stick, the needle broke in her hand, and separated from the syringe.There was medical intervention required to remove the needle, and stitches at the local.The event occurred on (b)(6) 2020; patient applies insulin 3 times a day and performs the application rotation.(info added on (b)(6) 2021): the caregiver's mother used insulin for more than 15 years, and always used bd.The patient suffered lost of sight but had no other limiting condition and was lucid.She had hired caregivers assisting her, but she continuously kept applying insulin by herself 3 times per day and never had problems.The patient used to receive the syringe, applied in herself, and performed the local rotation with assistance of her son.On (b)(6), 2020, one hired caregiver suffered an accident when, suddenly, got an used needle stick in her hand, and the needle released from the syringe and got stuck, leading her to need a medical intervention to remove it.The hired caregiver took the syringe in her right hand and injured her left hand, but it's unknown if the needle broke or separated from hub.It was usual for the caregiver to observe needles bending, but he has never seen a needle hub separation.The caregiver (patient's son) is concerned about a litigation, being sued, due to the accident, due to the needle hub separation/needle break, and he needs a backing regarding the product releasing specifications and quality control.He highlights he would like to receive information such as: the strength required to pull the needle and cause a needle hub separates, and the strength required to break a needle; he wants to eliminate the possibility of the needle had actually separated from hub; and he wants to prove that the needle does not release from hub neither breaks as easy as the hired caregiver reports.He looks for the quality standards, and product releasing criteria, so he can protect himself and get covered under a litigation/sue from the injured caregiver.A possible batch affected could be the 0027924, but it's impossible to be sure since his mother, unfortunately, has passed away.Due to the same fact, the caregiver doesn't want the product replacement.".

Manufacturer Narrative

H.6.Investigation: no samples were returned therefore the investigation was performed based on the photos provided.One photo of a polybag for bd insulin syringes was provided.It was reported that the caregiver suffered a needle stick, the needle broke in her hand, needle hub separation, and the needles were bending.The provided photo was examined, and it was observed that only a portion of the front of a syringe polybag was shown.No photos of a syringe was provided.No related defects were observed based on photo provided.A review of the device history record was completed for batch# 0027924.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications [(b)(6)] noted that did not pertain to the complaint.

• Brand Name: SYRINGE 1.0ML 30GA 8MM 10BAG 500 L AMR
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11749273
• MDR Text Key: 248756424
• Report Number: 1920898-2021-00491
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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 Catalogue Number: 328328
• Device Lot Number: 0027924
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention