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	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 the seal was found open on a bd¿ pen needle sterile single use breaching sterility.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that the seal was found open on a bd¿ pen needle sterile single use breaching sterility.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: customer returned a photo of a 7mm, 23g pen needle.Customer states that the needle was unsealed.The attached photo was examined and exhibited and incomplete seal between the tear drop label and outer cover.A review of the device history record was completed for batch # 6111750 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure investigation conclusion: unable to determine a root cause.

• 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: 7654986
• Report Number: 1920898-2018-00453
• Device Sequence Number: 11144146
• 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): 07/25/2018

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: 08/31/2021
• Device Catalogue Number: 47369802
• Device Lot Number: 6111750
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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