MAUDE Adverse Event Report: BD CARIBE LTD. BD TUBE MICRO W/MICROGARD SST GLD; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	365967
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd tube micro w/microgard sst gld, the device experienced poor separator movement (sst and pst all types).The following information was provided by the initial reporter.The customer stated: it was reported that the tube is not separating blood properly.Per email : hello! i am currently a user of your microtrainer brand tubes (yellow cap for serum collection https://www.Bd.Com/en-us/offerings/capabilities/specimen-collection/blood-specimen-collection/capillary-collection/bd-microtainer-blood-collection-tubes).Recently we have been having problems with the tube not separating the blood properly; instead the top layer becomes a soft gel and is not aspiratable.It happens pretty randomly and with only one lot of tubes.I just wanted to check and see if there was a recall on the lot.Lot number is 1055752 with expiration 2022-05-31 thanks in advance for your time and help!.
Event or Problem Description
It was reported when using the bd tube micro w/microgard sst gld, the device experienced poor separator movement (sst and pst all types).The following information was provided by the initial reporter.The customer stated: it was reported that the tube is not separating blood properly.Per email : hello! i am currently a user of your microtrainer brand tubes (yellow cap for serum collection https://www.Bd.Com/en-us/offerings/capabilities/specimen-collection/blood-specimen-collection/capillary-collection/bd-microtainer-blood-collection-tubes).Recently we have been having problems with the tube not separating the blood properly; instead the top layer becomes a soft gel and is not aspiratable.It happens pretty randomly and with only one lot of tubes.I just wanted to check and see if there was a recall on the lot.Lot number is 1055752, with expiration 2022-05-31.Thanks in advance for your time and help!.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12-nov-2021.H.6.Investigation: the next generation microtainer brand tube (ngmbt) is assembled in the arthur g.Russell ngmbt automatic assembly line (sap equipment number: 40069576) at the juncos, pr site.Fifteen (15) tubes are loaded onto racks that travel through each station in the machine.The lot number and expiration date are printed on the tubes, then the tubes inside walls are spray coated with a silica suspension.The tubes then pass through a drying station where the solution is dried.The barrier gel is dispensed in the next station.Then silicone lubricant is applied to the tube collector outside surface and then the cap is placed on the tube.The capped tubes are then transferred to the bagging equipment.The lot number, expiration date and secondary barcode are printed onto the polybag.Each tube is individually counted via a thru-beam sensor when it passes the slotted wheel.Tubes are accumulated until they reach 50, then a flap opens to transfer tubes into the polybag.After filling, the polybag is heat sealed.Polybags are then manually packed into case cartons.This automatic line has vision systems to 100% inspect for correct and legible tube lot/expiration date printing, solution spray presence, cap presence, cap seating, and polybag correct and legible lot / expiration date and barcode printing.Bd received 12 samples for investigation.The customer samples were evaluated along with 50 retention samples of the incident lot selected from bd inventory.The samples were tested and no issues relating to poor serum/plasma were observed.Return sample analysis: no difficulties were encountered during blood collection.Bd was unable to duplicate or confirm the customer¿s indicated failure (poor serum) because the defect was not evident in the testing of the complaint lot samples.Laboratory analysis of customer and control samples demonstrated clinically acceptable performance for all visual observations evaluated.These tubes performed as expected.Retain sample analysis: fifty (50) retention samples were evaluated for barrier gel characteristics with acceptable results.Of these retention samples forty-five (5) were evaluated for additive presence with acceptable results.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.This complaint is unable to be confirmed for the indicated failure mode.Bd was not able to identify a root cause.

• Brand Name: BD TUBE MICRO W/MICROGARD SST GLD
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12888054
• Report Number: 2618282-2021-00070
• Device Sequence Number: 16504203
• Product Code: JKA
• UDI-Device Identifier: 00382903659678
• UDI-Public: 00382903659678
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 365967
• Device Lot Number: 1055752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown