MAUDE Adverse Event Report: BD CARIBE LTD. SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	364902
Medical Device Problem Codes	Filling Problem (1233); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use with bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter there was a low draw and when removing tube leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: per customer's report, "when vacutainer luer-lok access device attached to iv tubing to obtain labs, blood return slow and then when taking off blood collection tube, blood kept coming out and saturated the inside of the vacutainer.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that during use with bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter there was a low draw and when removing tube leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: per customer's report, "when vacutainer luer-lok access device attached to iv tubing to obtain labs, blood return slow and then when taking off blood collection tube, blood kept coming out and saturated the inside of the vacutainer.".

• 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
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16713678
• Report Number: 2618282-2023-00026
• Device Sequence Number: 20626048
• 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): 04/12/2023

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: Other
• Device Model Number: 364902
• Device Catalogue Number: 364902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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