MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD MICRO-FINE ULTRA¿ PEN NEEDLE

Catalog Number	320141
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd micro-fine ultra¿ pen needle was clogged.This occurred on 10 occasions.The following information was provided by the initial reporter: a patient came along who has type 2 diabetes and regularly uses bd microfine needles 4mm.She already had several needles, namely 10, of the box with lot 8269503 of microfine ultra4mm 100 which needed tp be thrown away as they were clogged.Information received on 06/05: user didn't have any consequences, needles were clogged and she had to use the new one.She has been diabetic for years and has been using bd microfine 4mm.This was the first time, when she encountered this problem, fortunately with no consequences.She threw the needles away.
Additional Manufacturer Narrative
Investigation: no samples or photos were returned for analysis.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Complaint could not be confirmed and root cause is undetermined.
Event or Problem Description
It was reported that bd micro-fine ultra¿ pen needle was clogged.This occurred on 10 occasions.The following information was provided by the initial reporter: a patient came along who has type 2 diabetes and regularly uses bd microfine needles 4mm.She already had several needles, namely 10, of the box with lot 8269503 of microfine ultra4mm 100 which needed tp be thrown away as they were clogged.Information received on 06/05: user didn't have any consequences, needles were clogged and she had to use the new one.She has been diabetic for years and has been using bd microfine 4mm.This was the first time, when she encountered this problem, fortunately with no consequences.She threw the needles away.

• Brand Name: BD MICRO-FINE ULTRA¿ PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 8684266
• Report Number: 9616656-2019-00522
• Device Sequence Number: 19422918
• Product Code: FMI
• UDI-Device Identifier: 30382903814672
• UDI-Public: 30382903814672
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K131358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 320141
• Device Lot Number: 8269503
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other