MAUDE Adverse Event Report: COVIDIEN LP/LLC, DELAND MAGELLAN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881850115

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported foreign debris on the needle.From (b)(4) the customer reports: plastic fragments on the needles as well as missing information on the packaging.They immediately pulled stock and inspected the products.The plastic fragments were not isolated to 1 or 2 lots, but all lots from (b)(4) the customer reports: plastic fragments on the needles as well as missing information on the packaging.They immediately pulled stock and inspected the products.The plastic fragments were not isolated to 1 or 2 lots, but all lots.On (b)(6) 2018, additional information was received stating that there is excess oil or grease residue on the needles.

Manufacturer Narrative

A review of the device history records (dhr)¿s for the reported lot indicates that there were no issues noted during manufacturing of the lot.There were no devices returned to our facility for evaluation, therefore the reported issue and root cause could not be confirmed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAGELLAN
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN LP/LLC, DELAND; 2010 e international speedway; deland FL 32724 8707
• Manufacturer (Section G): COVIDIEN LP/LLC, DELAND; 2010 e international speedway; deland FL 32724 8707
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7316390
• MDR Text Key: 101633163
• Report Number: 1017768-2018-00022
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881850115
• Device Catalogue Number: 8881850115
• Device Lot Number: 724244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 02/14/2018
• Supplement Dates FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: No
• 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