Catalog Number 309597 |
Device Problems
Difficult to Remove (1528); Inadequate User Interface (2958)
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Patient Problem
No Code Available (3191)
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Event Date 03/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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¿ slip tip syringe with attached needle shield is hard to remove and it is difficult to push the needle into the patients leg.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 309597, batch no: 8059526.It was reported that the needle shields
are difficult to remove and that the user has scratched themselves in the past as a result.It was also reported that user was having difficulty pushing the needle into their leg.Event description per customer's complaint form states, "a report was received 28feb2019 via med info.With shire ae line transferred a patient that takes gattex for the treatment of short bowel syndrome.The caller stated "i have been using gattex now for 8 months, but this last month i have i have noticed that when i push the needle into my leg the skin on my leg is so tough it's like there is scar tissue under there.I only inject the medication in my legs.It's really hard trying to take the caps off the needles too.I can't take caps off due to my arthritis in my middle finger, it does not bend well." no further information provided.Ae filed for skin is tough feels like scar tissue is under skin.Pc filed for patient having difficulty taking the caps off the needle.Lot# unknown.".
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Manufacturer Narrative
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H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, 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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Event Description
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It was reported that bd¿ slip tip syringe with attached needle shield is hard to remove and it is difficult to push the needle into the patients leg.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 309597 batch no: 8059526 it was reported that the needle shields are difficult to remove and that the user has scratched themselves in the past as a result.It was also reported that user was having difficulty pushing the needle into their leg.Event description per customer's complaint form states, "a report was received 28feb2019 via med info.With shire ae line transferred a patient that takes gattex for the treatment of short bowel syndrome.The caller stated "i have been using gattex now for 8 months, but this last month i have i have noticed that when i push the needle into my leg the skin on my leg is so tough it's like there is scar tissue under there.I only inject the medication in my legs.It's really hard trying to take the caps off the needles too.I can't take caps off due to my arthritis in my middle finger, it does not bend well." no further information provided.Ae filed for skin is tough feels like scar tissue is under skin.Pc filed for patient having difficulty taking the caps off the needle.Lot# unknown.".
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Search Alerts/Recalls
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