MAUDE Adverse Event Report: BD CARIBE LTD. BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE/ PRE-ATTACHED MULTI SAMP ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 364902

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter, the device experienced unable to fill tube completely.The following information was provided by the initial reporter.The customer stated: unable to draw blood.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-29.H6: investigation summary: bd received 1 used sample and 1 photo for investigation.The sample and photo were reviewed and the indicated failure mode for unable to draw blood with the incident lot was not observed.The sample had blood on the inner diameter of the luer hub but did not show any signs of leakage or damaged components.Additionally, 12 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to unable to draw 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 unable to draw blood.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter, the device experienced unable to fill tube completely.The following information was provided by the initial reporter.The customer stated: unable to draw blood.

• Brand Name: BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE/ PRE-ATTACHED MULTI SAMP 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13158758
• MDR Text Key: 284839003
• Report Number: 2618282-2021-00082
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903649020
• UDI-Public: 00382903649020
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 364902
• Device Lot Number: 1020968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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