Model Number 305269 |
Device Problems
Break (1069); Defective Component (2292)
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Patient Problems
Swelling/ Edema (4577); Insufficient Information (4580)
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Event Date 12/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd integra 3ml syringe experienced difficult plunger movement, clogged needle, and a needle that broke.The product defects led to the patient receiving medical intervention.They were admitted to the emergency room where they received x-ray scans, but a broken portion of the cannula was not found.Muscle damage was discovered, likely from pushing too hard on the syringe.The following information was provided by the initial reporter: stated, she took her son to emergency room.Stated, a few xrays were taken and there was no needle found.Stated, she was told there was some muscle damaged that could have been caused from pushing syringe too hard or infection.Stated, her son was told to take ibuprofen for the swelling and follow up if swelling does not go down.Parent reported, needle broke off into her son's arm when she was administering his shot.Stated, she had to push really hard on the syringe to get medication to come out.Stated, when using the syringes from this lot, she has to push really hard because medication is too thick stated, her son's arm is now "swollen and hard to the touch".
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd integra 3ml syringe experienced difficult plunger movement, clogged needle, and a needle that broke.The product defects led to the patient receiving medical intervention.They were admitted to the emergency room where they received x-ray scans, but a broken portion of the cannula was not found.Muscle damage was discovered, likely from pushing too hard on the syringe.The following information was provided by the initial reporter: stated, she took her son to emergency room.Stated, a few xrays were taken and there was no needle found.Stated, she was told there was some muscle damaged that could have been caused from pushing syringe too hard or infection.Stated, her son was told to take ibuprofen for the swelling and follow up if swelling does not go down.Parent reported, needle broke off into her son's arm when she was administering his shot.Stated, she had to push really hard on the syringe to get medication to come out.Stated, when using the syringes from this lot, she has to push really hard because medication is too thick stated, her son's arm is now "swollen and hard to the touch".
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Event Description
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It was reported that bd integra 3ml syringe experienced difficult plunger movement, clogged needle, and a needle that broke.The product defects led to the patient receiving medical intervention.They were admitted to the emergency room where they received x-ray scans, but a broken portion of the cannula was not found.Muscle damage was discovered, likely from pushing too hard on the syringe.The following information was provided by the initial reporter: stated, she took her son to emergency room.Stated, a few xrays were taken and there was no needle found.Stated, she was told there was some muscle damaged that could have been caused from pushing syringe too hard or infection.Stated, her son was told to take ibuprofen for the swelling and follow up if swelling does not go down.Parent reported, needle broke off into her son's arm when she was administering his shot.Stated, she had to push really hard on the syringe to get medication to come out.Stated, when using the syringes from this lot, she has to push really hard because medication is too thick stated, her son's arm is now "swollen and hard to the touch".
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Manufacturer Narrative
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The following fields were updated due to additional information: device available for eval yes.Returned to manufacturer on: 2022-02-22.Investigation summary one loose 3ml integra syringe (p/n 305269) was received and evaluated.There was also a top web slip with the batch # 9268944 on it.The sample was an activated integra syringe with the needle present in the bottom of the outer plunger rod.No visual defects were observed on the syringe.Please note that this product has a retractable needle design.The metal cannula of the needle retracts into the inner plunger rod for safety.Since the sample received did not display the reported condition a potential root cause could not be defined, and corrective actions are not necessary.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
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Search Alerts/Recalls
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