MAUDE Adverse Event Report: BD CARIBE LTD. BD LUER-LOK ACCESS DEVICE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 36490200

Device Problem Complete Blockage (1094)

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

Event Date 04/13/2022

Event Type  malfunction  

Event Description

It was reported when using the bd luer-lok access device, the device experienced a clogged / blocked cannula.This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: the flow is obstructed in some of the adapters.Sometimes they need to change multiple times to get flow and filling the tubes.

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd luer-lok access device, the device experienced a clogged / blocked cannula.This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: the flow is obstructed in some of the adapters.Sometimes they need to change multiple times to get flow and filling the tubes.

Manufacturer Narrative

H6: investigation summary bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.H3 other text : see h10.

• Brand Name: BD LUER-LOK ACCESS DEVICE
• 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: 14438044
• MDR Text Key: 292073241
• Report Number: 2618282-2022-00025
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903649020
• UDI-Public: 00382903649020
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 36490200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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