Catalog Number 1029-104-090 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is (b)(4).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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1263568, medical device expiration date: na, device manufacture date: 2021-09-20.Medical device lot #: 1291851, medical device expiration date: na, device manufacture date: 2021-10-18.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 foreign particles were found on 19 bd¿ female adapters from lot 1263568, and 5 adapters from lot 1291851 during an inspection.The following information was provided by the initial reporter: "at incoming inspection it has been reported via (b)(4) that the material has contamination.According to the s31-090 rev 102.Sec.5 "cleanliness" the parts shall be free of embedded particles exceeding 0.2 mm² in size.Parts shall be free of loose or adherent particulate exceeding 0.04 mm² in size and the parts measure with tappi chart states 2.5 mm².".
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Event Description
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It was reported that foreign particles were found on 19 bd¿ female adapters from lot 1263568, and 5 adapters from lot 1291851 during an inspection.The following information was provided by the initial reporter: "at incoming inspection it has been reported via ncr000126 that the material has contamination.According to the s31-090 rev 102.Sec.5 "cleanliness" the parts shall be free of embedded particles exceeding 0.2 mm² in size.Parts shall be free of loose or adherent particulate exceeding 0.04 mm² in size and the parts measure with tappi chart states 2.5 mm².".
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Manufacturer Narrative
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H.6.Investigation: a complaint of a product being found contaminated during inspection was received from the customer.A photo was provided for investigation of this defect.It was found that the screw and manifold had arears of degraded material buildup.Due to pvc being a thermal and shear sensitive material susceptible to degradation when exposed to excessive heat or delays in the molding process, embedded fm was observed on the product due to degraded material buildup.Material degradation leading to build up is a common phenomenon for pvc if the material has been left in the screw for the prolonged operating times caused as a result of increased opportunity for the pvc to be exposed to heat.Therefore, material build-up in certain areas on the screw or in the manifold is then susceptible to breaking loose during normal operating conditions.A device history record review for model 1029-104-090 lot number 1291851 was performed.Since production start-up for part number 1029-104-090 nine (9) qn's were opened related to embedded fm.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of foreign matter with lot #1263568 regarding item 1029-104-090.H3 other text : see h.10.
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Search Alerts/Recalls
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