MAUDE Adverse Event Report: BD CARIBE LTD. SEE H.10

Catalog Number	36490200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter that there was poor sleeve function.The following information was provided by the initial reporter: this report is about blood leak.When the product was used for dispensing, the rubber sleeve on the needle did not return properly and bent.Blood leaked from the needle.
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 while using bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter that there was poor sleeve function.The following information was provided by the initial reporter: this report is about blood leak.When the product was used for dispensing, the rubber sleeve on the needle did not return properly and bent.Blood leaked from the needle.
Additional Manufacturer Narrative
The following fields have been updated: site legal name (fda) has been updated to: bd caribe ltd - (b)(6).D3: medical device manufacturer: bd caribe ltd.G1: manufacturing location: bd caribe ltd.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for investigation.Therefore, 24 retention samples from bd inventory were evaluated by visual examination and another 12 retention samples by functional testing, and no issues were observed relating to sleeve 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 sleeve leakage.Bd was not able to identify a root cause for the indicated failure mode.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 while using bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter that there was poor sleeve function.The following information was provided by the initial reporter: this report is about blood leak.When the product was used for dispensing, the rubber sleeve on the needle did not return properly and bent.Blood leaked from the needle.

• Brand Name: SEE H.10
• Common Device Name: NA
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17466874
• Report Number: 2243072-2023-01370
• Device Sequence Number: 8975939
• Product Code: JKA
• UDI-Device Identifier: 50382903649025
• UDI-Public: 50382903649025
• 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,Followup,Followup
• Report Date (Section B): 09/14/2023

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: 09/30/2025
• Device Catalogue Number: 36490200
• Device Lot Number: 2280975
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 08/08/2023; 09/14/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/11/2023; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2022
• 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
• Patient Sex: Unknown