Catalog Number 385703-ZAT |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturing location for this product is atom.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that iv set/j/60drop/2cq/re/f/sb/50cm/pb was cracked during used.
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Manufacturer Narrative
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The actual device was returned, and cracks were recognized in the tube.The cross section of the cracked part had a distorted shape.In addition, this product was conducting the all-in-one visual inspection just before putting it into individual packaging.From the shape of the cross section of the crack, etc., it was presumed that this event was cracked by locally being sandwiched between objects like forceps during use.As described in the package insert, handling may cause damage or cracking, so please be careful when handling the product.A review of the device history record could not be performed as a lot number was not provided for this incident.
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Event Description
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It was reported that iv set/j/60drop/2cq/re/f/sb/50cm/pb was cracked during used.
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Event Description
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It was reported that iv set/j/60drop/2cq/re/f/sb/50cm/pb was cracked during used.
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Manufacturer Narrative
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Correction: in the previously submitted mdr, sections were incorrectly referenced as the medical device expiration date and device manufacture date.This supplemental mdr is being submitted to correct those references to show the following: medical device expiration date device manufacture date.
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Search Alerts/Recalls
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