Date of event: unknown.
The date received by manufacturer has been used for this field.
Device expiration date: unknown.
Device manufacture date: unknown.
Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.
Based on the limited investigation results, a cause for the reported incident could not be determined.
Complaints received for this device and reported condition will continue to be tracked and trended.
Our quality team regularly reviews the collected data for identification of emerging trends.
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It was reported that an unspecified number of bd 20ml syringe luer-lok¿ tips experienced difficult plunger movement during use.
The following information was provided by the initial reporter: material no.
302830 batch no.
Unknown.
We have been asked for device and/or drug delivery ideas, by nursing staff experiencing upper extremity strain due to prolonged manual delivery of viscous chemo meds via syringe, iv push or subcutaneous, taking 5 ¿ 45 minutes at a time.
(they are reaching out to other jurisdictions, looking at body mechanics, etc, in addition to these enquiries.
).
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