MAUDE Adverse Event Report: COVIDIEN SAFETY NEEDLE 25 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881850510

Device Problems Leak/Splash (1354); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

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.

Event Description

The customer states the item has fiber contamination and leaking hubs.

Manufacturer Narrative

A review of the device history reports (dhrs) for lot no.820844 and 821923 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.The dhrs for shop order production of the safety needles and molded safety shields identified no issues.There were no ncrs issued against the shop orders.A review of the entire dhr identified no manufacturing or inspection anomalies.A review of maintenance records (both corrective and preventive) and calibration records showed no issues related to the reported condition.All scheduled maintenance and calibration activities were completed.There were no process or material changes related to the reported condition for this product.Additionally, a review of the machine setup was conducted and revealed no issues.A review of the manufacturing equipment was performed as part of this investigation.The review found no issues with the equipment or process related to the reported condition.Since the complaint of hub leaks could not be confirmed, but the string flash was confirmed, it was decided to leverage an existing complaint (b)(4) to satisfy this investigation.There were seventeen (17) needle assemblies and one (1) empty unit package (opened) returned with this complaint.The unit package was labeled with item number 8881850510, lot 821923.There was no other labeling provided with this complaint.All needles were visually examined and had a very thin piece of string flash wrapping around the cannula.The string flash originated from the gate of the safety shield, so it¿s not foreign contamination of the device.The safety shields were examined and were imprinted with an indicator that traces to twelve (12) different cavities from mold number 823.There were three (3) subsequent samples (opened) received and evaluated.One (1) sample was from lot number 820100, a second was from lot number 821923 and a third was from an unknown lot number (potentially 820844).All samples were visually examined and had a very thin piece of string flash wrapping around the cannula.The string flash originated from the gate of the safety shield, so it¿s not foreign contamination of the device.The safety shield from lot 820100 was examined and was imprinted with an indicator that traces to mold number 824.The safety shield from lot 821923 was examined and was imprinted with an indicator that traces to mold number 823.The safety shield from the unknown lot was examined and was imprinted with an indicator that traces to mold number 823.The reported condition was observed within the samples.

• Brand Name: SAFETY NEEDLE 25 X 1
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5084524970
• MDR Report Key: 8152444
• MDR Text Key: 130040868
• Report Number: 1017768-2018-00537
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881850510
• Device Catalogue Number: 8881850510
• Device Lot Number: 820844
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2018
• 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: N
• Patient Sequence Number: 1