MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 30521104

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that before use of the bd¿ blunt filter needle with blunt fill tip had 12 incident where there was excessive epoxy on the connection of the hub and the needles.

Event Description

It was reported that before use of the bd¿ blunt filter needle with blunt fill tip had 12 incident where there was excessive epoxy on the connection of the hub and the needles.

Manufacturer Narrative

Investigation: one sample and three photos were received for evaluation.The sample has the white epoxy drip over on the plastic hub, therefore failure mode is verified.The photos show this problem.An epoxy drip over generally occurs when the epoxy applicator fails to shut off for a missing cannula.There are several contributing / possible factors.A dirty sensor that doesn¿t shut the epoxy off for a missing cannula.The epoxy pressure is too high.The epoxy applicator needs attention ¿ it isn¿t shutting off when it should.The epoxy viscosity is also related to temperature fluctuations.If the temperature goes up, the epoxy gets thinner and flows faster.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

• Brand Name: BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8298745
• MDR Text Key: 134975981
• Report Number: 1911916-2019-00136
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903052110
• UDI-Public: 00382903052110
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 30521104
• Device Lot Number: 7291803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other