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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 367861
Device Problems Defective Component (2292); Device Ingredient or Reagent Problem (2910)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes have additive abnormality and seemed discolored.The following information was provided by the initial reporter.The customer stated: "it was reported by the customer that tubes have additive abnormality and seemed discolored.".
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval: yes d9: returned to manufacturer on: 2022-08-30 h.6.Investigation summary: bd received 2300 samples and 2 photos for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode for additive abnormality was observed however the reported issue of damage was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Bd was able to confirm the customer¿s indicated failure mode of additive abnormality with the samples and photos provided; however, damage could not be seen.Bd determined that the root cause of the indicated failure mode was attributed to a machine misalignment within the manufacturing process.H3 other text : see h.10.
 
Event Description
It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes have additive abnormality and seemed discolored.The following information was provided by the initial reporter.The customer stated: "it was reported by the customer that tubes have additive abnormality and seemed discolored." (b)(6) : 2022-08-26 16:05:01 (gmt) subject: email 8/26/2022, 11:02:57 am user: (b)(6) created on: 2022-08-26 16:02:57 call activity comment: customer states returns will be sent out on 8/26 (b)(6) : 2022-08-26 14:35:15 (gmt) subject: email 8/26/2022, 9:09:02 am user: (b)(6) created on: 2022-08-26 14:09:02 call activity comment: fedex label sent (b)(6) : 2022-08-25 12:57:10 (gmt) subject: email 8/25/2022, 7:42:38 am user: (b)(6) created on: 2022-08-25 12:42:39 call activity comment: request shipping address confirmation material no.367861 batch no.2018857 it was reported by the customer that tubes have additive abnormality and seemed discolored.(b)(6): 2022-08-23 16:06:56 (gmt) subject: email 8/23/2022, 10:58:12 am user: (b)(6) created on: 2022-08-23 15:58:12 call activity comment: shipping address confirmation requested (b)(6) : 2022-08-23 16:06:07 (gmt) customer problem: customer states tubes have burn/moldy appearance.Many tubes are foggy and the edta seems clumped.Steps taken with customer/troubleshooting: customer replied to questions.Did the specimen(s) need to be recollected? not customers knowledge.Did exposure to blood/ bf occur? not customers knowledge.If exposure occurred was there any post exposure testing or medical intervention? not customers knowledge.Next steps (if necessary): process fedex label for returns.Resolution achieved (y/n)? : y shipment/storage/condition upon receipt: shipment: unknown temperature (we don¿t temp regular deliveries at the ww dock).Nothing out of the ordinary in regard the condition of the cases.Storage: our backstock location is at the dock where temps fluctuate based on season anywhere between 68-74 degrees.We have not had any days in the last few months outside of this range.Quantity received and quantity affected: 3 cases exhibit damage shipment method (directly or via distributor): unknown photos or returns requested?: photos attached.Returns requested (3 cases available for return ) follow up required y/n?: n reviewed smax case history: y.(b)(6) : 2022-08-23 14:33:23 (gmt) subject: email 8/23/2022, 9:18:30 am user: (b)(6) created on: 2022-08-23 14:18:30 call activity comment: returns available (b)(6) : 2022-08-23 14:32:50 (gmt) customer states 3 cases available for return.Awaiting response to remaining questions.(b)(6) : 2022-08-22 19:52:06 (gmt) subject: email 8/22/2022, 2:31:40 pm user: (b)(6) created on: 2022-08-22 19:31:40 call activity comment: additional information requested (b)(6) : 2022-08-22 19:50:38 (gmt) customer problem: customer states tubes have burn/moldy appearance.Many tubes are foggy and the edta seems clumped.Steps taken with customer/troubleshooting: asked customer for additional information did the specimen(s) need to be recollected? pending did exposure to blood/ bf occur? pending if exposure occurred was there any post exposure testing or medical intervention? pending next steps (if necessary): awaiting customer response resolution achieved (y/n)? : n shipment/storage/condition upon receipt: pending quantity received and quantity affected: 3 cases exhibit damage shipment method (directly or via distributor): pending if it is a distributor or directly from bd ¿ who is it? pending photos or returns requested?: photos attached.Returns requested follow up required y/n?: y.Reviewed smax case history: y.(b)(6) : 2022-08-22 19:41:47 (gmt) customer states tubes have burnt appearance and many tubes have clumped media and seem foggy and moldy.
 
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Brand Name
BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer (Section G)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15423202
MDR Text Key301524271
Report Number1917413-2022-00566
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903678612
UDI-Public50382903678612
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK050036
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2023
Device Model Number367861
Device Catalogue Number367861
Device Lot Number2018857
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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