MAUDE Adverse Event Report: BD CARIBE LTD. BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	364880
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.Medical device lot #: unknown medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary material #: 364880 lot/batch #: unknown bd received 1 used sample for investigation.The sample was evaluated by visual examination and the rubber sleeve was confirmed to be trapped in the terumo blood collection tube closure.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.The competitor containment device (blood collection tube) used in conjunction with our btd and other acquisition products sometimes is incompatible due to the design of the closure of the tube.Other stopper designs in rare cases can trap the btd sleeve, causing it to pull off or be trapped and exposing the non-patient (np) needle.Without the sleeve in place, leakage occurs.This closure design is not as robust as the bd tubes in which the closure is a soft rubber stopper material which does not allow the sleeve to get caught or hung up.The sleeve compresses on top of the stopper allowing the np needle to pierce through the stopper material allowing blood flow.Once removing the tube from the np end, the sleeve then safely retracts back over the np needle (without any leakage) allowing the phlebotomist the opportunity to transfer another tube safely for collection.Complaints received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
It was reported that while using the bd vacutainer® blood transfer device holder with female luer adapter that the non-patient sleeve detached from the device causing blood leakage.No impact was reported.

• Brand Name: BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19172888
• Report Number: 2618282-2024-00031
• Device Sequence Number: 12717172
• Product Code: JKA
• UDI-Device Identifier: 50382903648806
• UDI-Public: (01)50382903648806
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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 Catalogue Number: 364880
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/24/2024
• 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