MAUDE Adverse Event Report: BD BD MICRO-FINE PLUS 32GA X 4MM PEN NEEDLE; PEN NEEDLE, 32G X 4MM

Catalog Number 320136

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Inflammation (1932)

Event Date 06/13/2014

Event Type  Injury  

Event Description

Redness and swelling appeared at the injection site after the needle was changed from a novo pen needle 32 ga x 6mm to a micro-fine plus 32g x 4mm.Ointment was prescribed by the hosp, but it did not resolve the issue.

Manufacturer Narrative

Results: the sample is not available for evaluation.A review of the device history records could not be performed as a lot number for this incident was not provided.Conclusions: without a sample, a root cause for this incident could not be identified.Pir #: (b)(4).

• Brand Name: BD MICRO-FINE PLUS 32GA X 4MM PEN NEEDLE
• Type of Device: PEN NEEDLE, 32G X 4MM
• Manufacturer (Section D): BD; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer (Section G): POTTERY RD; dun laoghaire, co.; dublin ; EI
• Manufacturer Contact: amy bodell ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652585
• MDR Report Key: 4017751
• MDR Text Key: 4712198
• Report Number: 2243072-2014-00159
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention