BECTON, DICKINSON & CO. (SPARKS) BD VERITOR¿ SYSTEM STREP A TEST KIT; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
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Model Number 256040 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device lot #: 6982 was reported, however, this is not a lot# manufactured for this product #.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that while using the bd veritor¿ system strep a test kit, the tip fell off the patient's mouth.There was no indication of discomfort nor patient impact.The following information was provided by the initial reporter: "customer says the swab tip is falling off in patients mouth.Ver 256040 lot: 6982 exp: 1/1/2025 potential hazard for patient if nihilated or swallowed.".
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Manufacturer Narrative
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H6: investigation summary: this summarizes the investigation results regarding the complaint that alleges when using kit grp a strep 30 test veritor (material # 256040), batch number 6982, the swab tip fell in the customer mouth.Bd quality performs a systematic approach to investigate complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation could not be performed because the batch number provided was for the swab and not the kit.The noted swab batch number went into 20 different kit grp a strep 30 test veritor (material # 256040) batch numbers.Unable to determine which batch was associated with this complaint.The complaint was unable to be confirmed.The root cause could not be identified.A trend analysis for safety (broken swab) was conducted, no adverse trend was identified.H3 other text : see h10.
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Event Description
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It was reported that while using the bd veritor¿ system strep a test kit, the tip fell off the patient's mouth.There was no indication of discomfort nor patient impact.The following information was provided by the initial reporter: "customer says the swab tip is falling off in patients mouth.Ver 256040 lot: 6982 exp: 1/1/2025 potential hazard for patient if nihilated or swallowed.".
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Search Alerts/Recalls
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