MAUDE Adverse Event Report: BD CARIBE LTD. BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	364902
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date of this event is unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.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 that the bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter was spraying blood from device during blood collection.This report is to capture the incident with the unknown date and lot #.The following information was provided by the initial reporter: having constant issue with lot#: 3009386."blood is spraying from device during blood collection.While collecting blood from a venous non-valued vascular access device, using a transfer device (vacutainer) directly connected to a clear-link connector via leurlock and laboratory tube inserted into puncture side of the vacutainer, blood sprayed onto the wall and approximately 3 feet across room during collection, suspected that it occurred when removing collection tube from vacutainer device.This same event occurred a week prior with another patient, another type of collection tube, and another staff member performing the draw.We cannot confirm this vacutainer lot number was involved in this previous event." was there blood exposure? information not available.If yes, where did the exposure occur to? (was it the eye, mouth, open cut, etc).Information not available.Was medical intervention required or necessary? no.Any other patient impact? no.
Event or Problem Description
It was reported that the bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter was spraying blood from device during blood collection.This report is to capture the incident with the unknown date and lot #.The following information was provided by the initial reporter: having constant issue with lot#: 3009386."blood is spraying from device during blood collection.While collecting blood from a venous non-valued vascular access device, using a transfer device (vacutainer) directly connected to a clear-link connector via leurlock and laboratory tube inserted into puncture side of the vacutainer, blood sprayed onto the wall and approximately 3 feet across room during collection, suspected that it occurred when removing collection tube from vacutainer device.This same event occurred a week prior with another patient, another type of collection tube, and another staff member performing the draw.We cannot confirm this vacutainer lot number was involved in this previous event." was there blood exposure? information not available if yes, where did the exposure occur to? (was it the eye, mouth, open cut, etc) information not available.Was medical intervention required or necessary? no.Any other patient impact? no.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 43 samples for investigation.The samples were evaluated by visual examination and functional leakage testing and the indicated failure mode for leakage with the incident lot was not observed.Additionally, 24 retention samples from bd inventory were evaluated by visual examination and another 12 retention samples by functional leakage testing and no issues were observed relating to leakage as all samples met specifications.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 leakage.Bd was not able to identify a root cause for the indicated failure mode." the following fields were updated due to additional information: d9: device available for evaluation:  yes.D9: returned to manufacturer on: 2023-06-30.

• Brand Name: BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED ADAPTER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17209744
• Report Number: 2618282-2023-00049
• Device Sequence Number: 15119979
• Product Code: JKA
• UDI-Device Identifier: 50382903649025
• UDI-Public: 50382903649025
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K991088
• 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): 06/30/2023

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: Health Professional
• Device Model Number: 364902
• Device Catalogue Number: 36490200
• Device Lot Number: UNKNOWN
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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