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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE .5ML; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE .5ML; PISTON SYRINGE Back to Search Results
Catalog Number 328520
Device Problem Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that prior to use with relion¿ insulin syringe.5ml the plunger rod and cap was missing.The following information was provided by the initial reporter: it was reported that plunger rod and plunger cap was missing from syringe.
 
Event Description
It was reported that prior to use with relion¿ insulin syringe.5ml the plunger rod and cap was missing.The following information was provided by the initial reporter: it was reported that plunger rod and plunger cap was missing from syringe.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/9/2021.H.6.Investigation: customer returned (1) 1/2cc, 6mm, 31g relion syringe in an open poly bag from lot # 9346553.Customer states that the plunger cap was missing and that the plunger rod was missing.The returned syringe was examined and exhibited a missing plunger rod and cap.A review of the device history record was completed for batch# 9346553.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.Raised caps t the assembly operation could lead to a missing cap when transferring to the packaging operation.Dial for plungers is out of time causing issues with the assembly of the syringe.H3 other text : see h.10.
 
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Brand Name
RELION INSULIN SYRINGE .5ML
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key11233701
MDR Text Key230109293
Report Number1920898-2021-00108
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00681131138376
UDI-Public00681131138376
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328520
Device Lot Number9346553
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Date Manufacturer Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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