MAUDE Adverse Event Report: COEUR, INC. 150CC POWER INJECTOR SYRINGE; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number 77-400277

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

An internal complaint (b)(4) was received indicating that the plunger of a syringe (part number (b)(4), lot iaf661510) became crooked, allowing for contrast fluid to leak.A sample was received for evaluation.The sample and a supplier corrective action request (scar) were forwarded to coeur, inc., who supplies the syringe to deroyal.A reply is due back (b)(6), 2016.The investigation is ongoing at this time.This report will be updated when new and critical information is received.

Event Description

The plunger became crooked within the shaft causing contrast to spill out.The syringe had to be changed, causing a delay of less than a minute.The product was being used in an angiography procedure with a mark 5 power injector.

Manufacturer Narrative

Root cause: the syringe is supplied to deroyal by (b)(4).Therefore, a supplier corrective action response (scar) was issued to coeur.In its response, (b)(4) stated it was unable to determine a true root cause.In reviewing the returned and retained samples, the device history record, and the fixtures used during assembly, (b)(4) confirmed the device was assembled correctly.A possible root cause is misalignment by the end user.Corrective action: in its scar response, (b)(4) stated it has issued a quality alert to raise awareness among its operators, assemblers, and inspection personnel of the need for proper plunger alignment.Investigation summary: an internal complaint (call (b)(4)) was received indicating that the plunger of a syringe (part number 77-400277, lot iaf661510) became crooked, allowing for contrast fluid to leak.A sample was received for evaluation.The sample and a supplier corrective action request (scar) were forwarded to (b)(4), who supplies the syringe to deroyal.A reply was due november 22, 2016, and received december 15, 2016.Deroyal quality personnel has reviewed and accepted the response.In its response, (b)(4) stated it reviewed the returned samples as well as retained samples and found them to be assembled correctly and functioning properly.It also reviewed the fixtures and confirmed they are building product correctly.Deroyal personnel reviewed the reported lot number for discrepancies that may have contributed to the reported event.No discrepancies were identified.Preventive action: a preventive action has not been taken.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

The plunger became crooked within the shaft causing contrast to spill out.The syringe had to be changed, causing a delay of less than a minute.The product was being used in an angiography procedure with a mark 5 power injector.

• Brand Name: 150CC POWER INJECTOR SYRINGE
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): COEUR, INC.; 209 creekside dr; washington NC 27889
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: elizabeth reed ; 200 debusk lane; powell, TN 37849 ; 8653621256
• MDR Report Key: 6060525
• MDR Text Key: 58614398
• Report Number: 1060680-2016-00036
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K823920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 77-400277
• Device Lot Number: IAF661510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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