DBC SPRINGTEN 0.25X30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-10-30 for DBC SPRINGTEN 0.25X30 manufactured by .

Event Text Entries

[959106] As follow up to filed in 2008, new acupuncture needles from different mfr were ordered to replace the previously reported faulty packages. On the following month, we discovered a similar problem with five packages of dbc springten 0. 25x30, expiration date 2011-06 singe use acupuncture needles. These are packages that contain multiple (10) loose needles plus a guide tube in sterile packaging. It appears that through shipping and handling, in some instances, the tips of the needles have penetrated the plastic sheath and protrude from the package compromising both sterility and creating a needle stick hazard. We took digital pictures of the packaging, contacted our supplier and provided them with copies of the photos. Both this supplier and the previous supplier have indicated correspondence with the mfr's and that steps were being taken to correct the packaging. We have requested written documentation, but have not yet received any. Please note that this was discovered during the normal course of business and was not as a result of an adverse event.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5008835
• MDR Report Key: 1217529
• Date Received: 2008-10-30
• Date of Report: 2008-10-30
• Date of Event: 2008-09-25
• Date Added to Maude: 2008-11-07
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DBC SPRINGTEN 0.25X30
• Generic Name: ACUPUNTURE NEEDLES
• Product Code: MQX
• Date Received: 2008-10-30
• Device Expiration Date: 2011-06-01
• Device Availability: Y
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 1268138

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-10-30