MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ PEN NEEDLE STERILE SINGLE USE; INSULIN PEN NEEDLE

Catalog Number	47369802
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that packages of bd¿ pen needle sterile single use were found with defective covering, missing or punctured/tore breaching the sterile barrier.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: on (b)(6) 2018, the (b)(4) manufacturing plant received the following complaint samples: twenty (20) pen needles from batch# 7152646: defect(s) reported: during 100% inspection, 9 critical defects were identified: quantity: 8; defect: missing, damaged or defective label affecting sterility (3 punctured/teared; 5 not sealed) quantity: 1; defect: missing, damaged, or defective cover affecting sterility.Additionally, 13 major defects of interest that appear to be of similar root cause as the critical defects were found during 100% inspection: damaged, deformed, or defective cover and/or label not affecting sterility (11 cuts, tears to label and/or slight damage to cover where label damage occurs; 2 bottom hit to cover).A device history record review for catalog# 47369802, batch# 7152646 (23g etw x 7mm pen needle us).This batch was manufactured between 18aug2017 to 28aug2017.There were zero (0) notifications for any defects noted during manufacturing of this batch.Investigation summary: damage noted to the exterior of the cover and to the tear drop label, as noted in the sample photos above, was determined to be attributable to a previously unidentified station.At station 50, a paper support ledge is utilized to support the flow of label material.An unevenness between this support and the adjoining plate was found to be a contributing factor to damage found along the rim and/or side of the covers.Damage to the tear drop label was also noted while observing the production line running during evaluation in (b)(6) 2017.

• Brand Name: BD¿ PEN NEEDLE STERILE SINGLE USE
• Common Device Name: INSULIN PEN NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7532210
• Report Number: 1920898-2018-00332
• Device Sequence Number: 275882
• Product Code: FMI
• UDI-Device Identifier: 00382904736989
• UDI-Public: 00382904736989
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K110105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 47369802
• Device Lot Number: 7152646
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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