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

Catalog Number	36488000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 48 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to sleeve fall off 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 sleeve fall off.Bd was not able to identify a root cause for the indicated failure mode.Other brand containment devices (blood collection tube) used in conjunction with our btd and other acquisition products may result in incompatibility 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.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 np needle to pierce through 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.
Event or Problem Description
It was reported when using the bd vacutainer® blood transfer device holder with female luer adapter customer reports that the rubber sleeve was stuck during blood collection.The following information was provided by the initial reporter.The customer stated: "the rubber sleeve was stuck in the blood collection tube and fell out, causing blood leakage.".

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17620725
• Report Number: 2618282-2023-00070
• Device Sequence Number: 17680750
• Product Code: JKA
• UDI-Device Identifier: 50382903648806
• UDI-Public: 50382903648806
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• 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): 08/21/2023

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 36488000
• Device Lot Number: 2293413
• 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: 08/09/2023
• Initial Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• 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
• Patient Sex: Unknown