MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ BLUNT FILL NEEDLE; BLUNT/FILTER NEEDLE

Catalog Number 303129

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.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 before use of the bd¿ blunt fill needle there was coring; a piece of the product plug was found in the syringe.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: the manufacturing facility received the sample for evaluation.Upon examination a red/brown filament in fluid path was detected.The returned needle was examined under microscope without observing any damaged cannula point and well-deburred.Sample was tested (using different angles of penetration) using a lab vial with no difficulties and no particles from vials stopper fragmentation were found.A device history review was conducted and showed no abnormalities during the manufacturing process.Blunt fill needles are specially designed with unique 40° bevel to minimize coring effect and 1.5¿ long needle, to easily penetrate single and double septum barriers (rubber stoppers and iv bag septum¿s).When securing hub of needle to syringe, remove needle shield and ensure that needle punctures stopper at 90° to minimize risk of catching internal wall of vial stopper.Investigation conclusion: based on above results, available information, since review of dhr showed no indication or abnormalities of the alleged defect during needles manufacturing and taking into account the preventive measures and controls in place during the cannula manufacturing process, the coring effect (risk of catching internal wall of vial stopper) is unlikely to be caused by poor or insufficient de-burring process of the cannula.Nevertheless, the stopper conditions and the handling cannot be excluded to play a role which could have some potential implication in the coring effect issues.Needles blunt fill needle are specially designed with unique 40° bevel to minimize coring effect and 1.5¿ long, to easily penetrate single and double septum barriers (rubber stoppers and iv bag septum¿s).When secure hub of needle to syringe, remove needle shield and ensure that needle punctures stopper at 90° to minimize risk of catching internal wall of vial stopper.

• Brand Name: BD¿ BLUNT FILL NEEDLE
• Type of Device: BLUNT/FILTER NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7172114
• MDR Text Key: 96827319
• Report Number: 3002682307-2017-00156
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303129
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2017
• 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
• Patient Outcome(s): Other