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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER URINE COLLECTION CUP; SPECIMEN TRANSPORT AND STORAGE CONTAINER
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BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER URINE COLLECTION CUP; SPECIMEN TRANSPORT AND STORAGE CONTAINER Back to Search Results
Catalog Number 364941
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0342566.Medical device expiration date: 2022-11-30.Device manufacture date:2020-12-07.Medical device lot #: 0335623.Medical device expiration date: 2022-11-30.Device manufacture date: 2020-11-30.Medical device lot #: 0328540.Medical device expiration date: 2022-11-30.Device manufacture date: 2020-11-23.Investigation summary: bd had not received samples, but photos were provided for investigation.The photos were reviewed and only showed the shipping box and product label information.The indicated failure mode for white material in the cups with the incident lot was not observed in the photos.A review of the device history record for lot number 0335623 indicated a quality notification was raised for cloudy cups.However, lot passed all in-process and final quality checks for lot release.The device history records for lot numbers 0342566; 0328540; 0307421 were reviewed with no issues being identified.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported when using the bd vacutainer® urine collection cup there was foreign matter in tube; biological and non-biological.The following information was provided by the initial reporter: translated to english.The customer stated: "white material in the cup in 3 lot numbers.Before use.White material on the surface on the walls of the cup.".
 
Event Description
It was reported when using the bd vacutainer® urine collection cup there was foreign matter in tube; biological and non-biological.The following information was provided by the initial reporter: translated to english.The customer stated: "white material in the cup in 3 lot numbers.Before use.White material on the surface on the walls of the cup.".
 
Manufacturer Narrative
The following fields were updated due to additional information added in investigation: multiple lot numbers: there were multiple lot numbers reported to be involved.The information for the lot is listed below.D.4.Medical device lot #: 0321126; d.4.Medical device expiration date: 11/30/2022; h.4.Device manufacture date: 11/17/2020; d.10.Device available for evaluation: yes; d.11.Returned to manufacturer on: 4/20/2021; h.3.Device evaluated by manufacturer: yes.H.6.Investigation summary: bd received 30 samples (material # 364941, batch #'s 0321126 - 1; 0307421 ¿ 11; 0335623 ¿ 18) and photos for investigation.The photos were reviewed and only illustrated the shipping box and product label information.The indicated failure mode for white material in the cups with the incident lot was not observed in the photos.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for white material in the cups with the incident lot was observed.The normally clear plastic of the cup had a cloudy appearance, making it slightly opaque.Bd determined that the root cause of the indicated failure mode was attributed to water/moisture contamination around the molding tool involved.A review of the device history record for lot number 0335623 indicated a quality notification was raised for cloudy cups.However, lot passed all in-process and final quality checks for lot release.The device history records for lot numbers 0342566; 0328540; 0307421; 0321126 were reviewed with no issues being identified.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see.10.
 
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Brand Name
BD VACUTAINER URINE COLLECTION CUP
Type of Device
SPECIMEN TRANSPORT AND STORAGE CONTAINER
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK 
MDR Report Key11620574
MDR Text Key249971265
Report Number9617032-2021-00326
Device Sequence Number1
Product Code FMH
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2022
Device Catalogue Number364941
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2021
Date Manufacturer Received04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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