MAUDE Adverse Event Report: BD CARIBE LTD. SEE H.10; 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	05/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use with bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter leakage/splatter occurred when removing the vacutainer.Blood splatter went into rn's eyes.Patient had labs drawn to test for hiv, hep b and hep c.Rn flushed out his eyes with water for at least 5 minutes.The following information was provided by the initial reporter: "we had another occurrence of possible bd luer-lok access device malfunction but this time with a true blood exposure, which has not happened in the past.The packaging with the lot and reference number were tossed before the incident so we do not have those numbers." where specifically was the leakage? in this case, the rn reported the following: "i was in the process of removing a vacutainer after drawing labs and as i removed it blood splattered out of the vacutainer/iv pigtail.I was surprised at the amount of blood that had splattered out because i was not used to seeing that much come out after removing the vacutainer.The blood splattered into my face and my eyes.I flushed out my eyes with water for at least 5 minutes and reported the incident to my charge nurse, supervisor, and nurse manager." how many people were affected? one staff rn.Was there any post exposure testing or medical intervention? please describe in detail.Yes, we followed our bloodborne pathogen exposure protocol.Patient had labs drawn to test for hiv, hep b and hep c.Rn flushed out his eyes with water for at least 5 minutes.-was the facility's established blood/bf exposure protocol followed? yes -what testing, treatment and/or medical intervention(if any) were done to the affected individuals? rn flushed out his eyes with water for at least 5 minutes and reported incident to charge, supervisor and manager.No further testing for affected individual needed at this time.
Additional Manufacturer Narrative
D.1.Medical device brand name: bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter.H.3.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 during use with bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter leakage/splatter occurred when removing the vacutainer.Blood splatter went into rn's eyes.Patient had labs drawn to test for hiv, hep b and hep c.Rn flushed out his eyes with water for at least 5 minutes.The following information was provided by the initial reporter: " we had another occurrence of possible bd luer-lok access device malfunction but this time with a true blood exposure, which has not happened in the past.The packaging with the lot and reference number were tossed before the incident so we do not have those numbers." -where specifically was the leakage? in this case, the rn reported the following: "i was in the process of removing a vacutainer after drawing labs and as i removed it blood splattered out of the vacutainer/iv pigtail.I was surprised at the amount of blood that had splattered out because i was not used to seeing that much come out after removing the vacutainer.The blood splattered into my face and my eyes.I flushed out my eyes with water for at least 5 minutes and reported the incident to my charge nurse, supervisor, and nurse manager." -how many people were affected? one staff rn -was there any post exposure testing or medical intervention? please describe in detail.-yes, we followed our bloodborne pathogen exposure protocol.Patient had labs drawn to test for hiv, hep b and hep c.Rn flushed out his eyes with water for at least 5 minutes.-was the facility's established blood/bf exposure protocol followed? yes -what testing, treatment and/or medical intervention(if any) were done to the affected individuals? rn flushed out his eyes with water for at least 5 minutes and reported incident to charge, supervisor and manager.No further testing for affected individual needed at this time.
Additional Manufacturer Narrative
H.6.Investigation summary: "bd received 5 samples for investigation.The samples were evaluated by functional leak and torque testing and the indicated failure mode for splatter with the incident lot was not observed.Additionally, 12 retention samples from bd inventory were evaluated by functional leak and torque testing and no issues were observed relating to splatter 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 splatter.Bd was not able to identify a root cause for the indicated failure mode.".

• Brand Name: SEE H.10
• 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: 17035199
• Report Number: 2618282-2023-00041
• Device Sequence Number: 6393576
• Product Code: JKA
• UDI-Device Identifier: 50382903649025
• UDI-Public: (01)50382903649025
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 364902
• Device Catalogue Number: 36490200
• Device Lot Number: 2241884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown