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

Catalog Number	320141
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 needles are clogged.This was discovered during use.The following information was provided by the initial reporter: customer reported that needles are clogged.Patient indicated that part of the insulin did not come out of the needle at first, but that after holding it, suddenly a lot came out at once.Result: sore leg.Sometimes no insulin came out of the pen at all.
Additional Manufacturer Narrative
H.6.Investigation: eight sealed 32g x 4mm pen needle samples were returned from lot.No.8338565, cat.No.320141.A clog test was carried out on all eight samples as per tp700483 and no issues were observed.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.No issues were observed with the returned samples therefore no root cause can be identified.H3 other text : see h.10.
Event or Problem Description
It was reported that bd micro-fine ultra¿ pen needles are clogged.This was discovered during use.The following information was provided by the initial reporter: customer reported that needles are clogged.Patient indicated that part of the insulin did not come out of the needle at first, but that after holding it, suddenly a lot came out at once.Result: sore leg.Sometimes no insulin came out of the pen at all.

• 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: 8800222
• Report Number: 9616656-2019-00636
• Device Sequence Number: 13533312
• Product Code: FMI
• UDI-Device Identifier: 30382903814672
• UDI-Public: 30382903814672
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 08/21/2019

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: 11/30/2023
• Device Catalogue Number: 320141
• Device Lot Number: 8338565
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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