MAUDE Adverse Event Report: BD CARIBE LTD. BLOOD TRANSFER DEVICE

Model Number	364880
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the blood transfer device that the tube was not able to fill completely.The following information was provided by the initial reporter: according to the customer's report, when dispensing blood, air enters resulting in an insufficient volume of blood drawn by the tube.
Additional Manufacturer Narrative
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 the blood transfer device that tthe tube was not able to fill completely.The following information was provided by the initial reporter: according to the customer's report, when dispensing blood, air enters resulting in an insufficient volume of blood drawn by the tube.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-04-25.H.6.Investigation summary: bd received 198 samples for investigation.The samples were evaluated by visual examination and 12 of the samples by functional testing draw testing and the indicated failure mode for insufficient flow with the incident lot was not observed.Additionally, 12 retention samples from bd inventory were evaluated by functional draw testing and no issues were observed relating to insufficient flow 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 insufficient blood flow.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BLOOD TRANSFER DEVICE
• Common Device Name: NA
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16820346
• Report Number: 2618282-2023-00033
• Device Sequence Number: 7124677
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: 08/31/2025
• Device Model Number: 364880
• Device Catalogue Number: 36488000
• Device Lot Number: 2237948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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