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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGE AND NEEDLE HYPODERMIC SYRINGE AND NEEDLE

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGE AND NEEDLE HYPODERMIC SYRINGE AND NEEDLE Back to Search Results
Catalog Number 328325
Device Problems Bent (1059); Material Perforation (2205); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem Needle Stick/Puncture (2462)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation results: severity: s1; occurrence: a complaint history check was performed and this is the 1st related complaint for cannula through shield and needle stick on lot # 7044954. As per manufacturing, a review of the device history record was completed for batch# 7044954. All inspections and challenges were performed per the applicable operations qc specifications. There were four (4) notifications [(b)(4)] noted that did not pertain to the complaint. Two investigations were completed. One in the (b)(4) facility and one in (b)(4) facility. (b)(4) investigation summary: customer returned (10) 1/2cc, 8mm, 30g syringes in a sealed poly bag from lot # 7044954. Customer states that the needle was through the orange protection cap, perforated the package, and injured an employee. The returned poly bag was examined and exhibited one syringe with the cannula through the shield. Since one sample exhibited the cannula through the shield, exposing the cannula, a needle stick could occur. (b)(4) investigation summary: on 30jan2018, (b)(4) received ten (10) 0. 5ml, 8mm, 30g syringes in unopened polybag from batch # 7044954. All samples were decontaminated per hstr-17 prior to being evaluated. Upon evaluation by qe ah, similar findings were noted as found during initial investigation at (b)(4). Probable root cause is likely due to the cannula being bent during the shielding process on the needle lines. While the lines have a point inspect machine (pim) that passes an electrical current over the shield to detect any arcs, this type of inspection is not fail proof. Conclusion: bd was able to duplicate or confirm the customer¿s indicated failure (needle stick and cannula through shield). Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Possible root causes for needle through shield include: needle was bent during the shielding process and was not detected at the point inspect machine, where an electrical current is passed over the shield and ejects parts where an arc is detected. Additionally, needle through shield would have had to pass through undetected by the camera system utilized on the production line. Both systems are challenged at regular intervals during production. Based on the above, no capa is required at this time.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). 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 before use, a bd ultra-fine insulin syringe and needle was found with the needle bent and through the orange protection cap. The package was perforated injuring an employee. There was no report found of medical intervention needed or performed regarding the "employee injury. ".
 
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Brand NameBD ULTRA-FINE INSULIN SYRINGE AND NEEDLE
Type of DeviceHYPODERMIC SYRINGE AND NEEDLE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7113215
MDR Text Key284521224
Report Number1920898-2017-00369
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2022
Device Catalogue Number328325
Device Lot Number7044954
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/13/2017 Patient Sequence Number: 1
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