MAUDE Adverse Event Report: WOLF MEDICAL SUPPLY WOLF-PAK NORMAL SALINE IV 10ML FILL IN 12ML FLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number PS1012

Device Problem Degraded (1153)

Patient Problem No Information (3190)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

Initial information about this event was provided to aquabiliti by the private label manufacturer, wolf medical supply (wms).The information stated their (wms) customer encountered a syringe with a "rusty" color.Aquabiliti issued a return material authorization.The device exhibiting the "rusty" color was received and forwarded to the syringe manufacturer for evaluation.The syringe manufactured stated the reported condition ("rusty" color solution) was observed.A metal contaminant was found in the shoulder of the syringe.The contaminant was sent to a laboratory for composition analysis.The results showed the contaminant was a mixture of iron, chromium, aluminum, manganese, nickel, and zinc.The syringe manufacturer responded to us the source of contaminant was traced back to three potential deficiences at their manufacturing facility.Cleaning methods may be insufficiently established or may not have been properly followed, raw materials used in the construction of the syringe plunger tip may have been contaminated, or possible production equipment wear may be generating metals that contaminate the manufacturing process.The syringe manufacturer opened a formal corrective action for this issue, and their manufacturing and quality assurance personnel have been made aware of this complaint in an effort to focus attention on preventing this issue.

Event Description

A customer of wolf medical supply, inc.Encountered a syringe with a "rusty" color.

• Brand Name: WOLF-PAK NORMAL SALINE IV 10ML FILL IN 12ML FLUSH SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): WOLF MEDICAL SUPPLY; 13951 nw 8th st; ft. lauderdale FL 33325
• Manufacturer (Section G): WOLF MEDICAL SUPPLY, INC.; 13951 nw 8th st; ft. lauderdale FL 33325
• Manufacturer Contact: john beasley ; 5209 linbar dr; ste 640; nashville, TN 37211 ; 6158832633
• MDR Report Key: 5867403
• MDR Text Key: 51940146
• Report Number: 1000151124-2016-00004
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2017
• Device Model Number: PS1012
• Device Catalogue Number: PS1012
• Device Lot Number: KH04240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• 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
• Patient Outcome(s): Other