MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD¿ BLUNT FILL NEEDLE; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number 305180

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 that mixed product was found before use with a bd¿ blunt fill needle.The following information was provided by the initial reporter, "please see the below concern from the ems stonegate, calgary zone, regarding a blunt filled needle 18g x 1.5¿, (mf# (b)(4)), (lot# all).The concern: the non-filtered blunt fill needles required for the point of care testing devices are in a lookalike packaging with the filtered blunt fill needles.Labeling is identical except for slightly different colors and very small text that indicates if it is filtered needle.".

Manufacturer Narrative

Please consider this mdr as canceled as the information was revaluated and does not meet our reporting criteria.H3 other text : see.H.10.

Event Description

It was reported that mixed product was found before use with a bd¿ blunt fill needle.The following information was provided by the initial reporter, "please see the below concern from the ems stonegate, calgary zone, regarding a blunt filled needle 18g x 1.5¿, (mf#305180), (lot# all).The concern: the non-filtered blunt fill needles required for the point of care testing devices are in a lookalike packaging with the filtered blunt fill needles.Labeling is identical except for slightly different colors and very small text that indicates if it is filtered needle.".

• Brand Name: BD¿ BLUNT FILL NEEDLE
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8946386
• MDR Text Key: 159161227
• Report Number: 1911916-2019-00888
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 30382903051800
• UDI-Public: 30382903051800
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305180
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other