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

Model Number 364880

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Bd received 1 sample from the customer for investigation.The sample was evaluated by functional testing and the indicated failure mode for clog with the incident lot was not observed.Additionally, 15 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to clog 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 non-conformances during manufacturing of the product.

Event Description

It was reported with the use of the bd vacutainer blood transfer device holder with female luer adapter the tube was unable to fill completely.This event occurred 10 times.The following information was provided by the initial reporter: the customer stated "during transfer of blood, blood stopped flowing into tube halfway.This incidence occurred in 10 cases.In some of the 10 cases, there was a hissing sound; when the hcp then pushed the syringe plunger, the connection was rapidly separated and blood splashed around the place.".

• Brand Name: BD VACUTAINER BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 10774716
• MDR Text Key: 214804155
• Report Number: 2618282-2020-00090
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903648806
• UDI-Public: 50382903648806
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 364880
• Device Catalogue Number: 364880
• Device Lot Number: 0037170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1