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U.S. Department of Health and Human Services

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

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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 30GA 8MM 10BAG 500 L AMR PISTON SYRINGE Back to Search Results
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. ".
 
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Brand NameSYRINGE 1.0ML 30GA 8MM 10BAG 500 L AMR
Type of DevicePISTON 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11749273
MDR Text Key248756424
Report Number1920898-2021-00491
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328328
Device Lot Number0027924
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/29/2021 Patient Sequence Number: 1
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