MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILL NEEDLE; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number 305180

Device Problems Delivered as Unsterile Product (1421); Device Markings/Labelling Problem (2911)

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

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one photo was provided for evaluation.The photo shows a needle assembly with the plastic shield.The tip of the needle goes through the plastic shield wall.The reported condition is confirmed.The plastic hub is placed under the cannulator then the needle is positioned and assembled to the plastic hub adding the silicone to fix it after that a plastic hub is assembled.In this case the needle either was bent or not properly placed inducing that the needle went through the plastic shield and not detected in the next processes.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.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.Investigation conclusion: this is the 1st complaint for lot # 8331653 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: the root cause may have occurred during nip line assembly.The plastic hub is placed under the cannulator then the needle is positioned and assembled to the plastic hub adding the silicone to fix it after that a plastic hub is assembled.In this case the needle either was bent or not properly placed inducing that the needle went through the plastic shield and not detected in the next processes.Rationale: capa not required at this time.

Event Description

It was reported that the bd¿ blunt fill needle experienced needle point penetration through shield and a mix of product types in a pack.Product defects were noted prior to use.The following information was provided by the initial reporter: material no: 305180 batch no: 8331653.Needle supposed to be blunt, but was sharp instead.In its returned condition the needle had poked through the plastic red cover and was curved in shape.

• Brand Name: BD¿ BLUNT FILL NEEDLE
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10075838
• MDR Text Key: 196778415
• Report Number: 1911916-2020-00479
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 30382903051800
• UDI-Public: 30382903051800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 305180
• Device Catalogue Number: 305180
• Device Lot Number: 8331653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2018
• 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
• Patient Outcome(s): Other