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

Catalog Number 77-400277

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

An internal complaint ((b)(4) was received indicating that a syringe (finished good (b)(4) lot number iaflq1511) was malfunctioning.The customer reported the plungers became crooked, causing a loose seal and allowing contrast fluid to spill out.The syringe is supplied to deroyal by couer.Therefore, a supplier corrective action request (scar) has been sent to the vendor.Samples returned for evaluation also were forwarded to couer.The vendor confirmed via email july 27, 2016, that it had received the scar request and samples.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.None were identified.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

Customer reported that five or six syringes plungers would become crooked, causing a loss of seal in the syringe and allowing contrast to spill out.This has occurred over a three to six week period.

Manufacturer Narrative

The syringe is supplied to deroyal industries by coeur medical.Therefore, a supplier corrective action request (scar) was issued to coeur.In its response, coeur stated the root cause cannot be determined without more information and/or a defective sample.In its scar response, coeur stated it conducted a five-minute awareness review of the defect with personnel.An internal complaint (b)(4) was received indicating that a syringe (finished good (b)(4), lot number iaflq1511) was malfunctioning.The customer reported the plungers became crooked, causing a loose seal and allowing contrast fluid to spill out.Samples were returned for evaluation.However, these samples were not the actual defective product but from the same lot number.The syringe is supplied to deroyal by coeur.Therefore, a supplier corrective action request (scar) was sent to the vendor.The samples returned for evaluation also were forwarded to coeur.The vendor confirmed via email (b)(6) 2016, that it had received the scar request and samples.A response was received and accepted by deroyal personnel on (b)(6) 2016.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.None were identified.Coeur created a different style of assembly fixture to improve plunger assembly by fully seating the plunger.Coeur reviewed the change and observed more than 100 consecutive assemblies.No ill-fitting plunger assemblies occurred.Coeur will continue to perform random audits for the next 90 days.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

Customer reported that five or six syringes plungers would become crooked, causing a loss of seal in the syringe and allowing contrast to spill out.This has occurred over a three to six week period.

Manufacturer Narrative

Root cause: the syringe is supplied to deroyal industries by (b)(4).Therefore, a supplier corrective action request (scar) was issued to coeur.In its response, (b)(4) stated it was unable to determine a true root cause.In reviewing the returned 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.Investigation summary an internal complaint ((b)(4)) was received indicating that a syringe (finished good 77-400277, lot number iaflq1511) was malfunctioning.The customer reported the plungers became crooked, causing a loose seal and allowing contrast fluid to spill out.Samples were returned for evaluation.However, these samples were not the actual defective product but from the same lot number.The syringe is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request (scar) was sent to the vendor.The samples returned for evaluation also were forwarded to (b)(4).The vendor confirmed via email july 27, 2016, that it had received the scar request and samples.A response was received and accepted by deroyal personnel on august 23, 2016.An updated scar response was received january 31, 2017, with additional information.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.None were identified.Preventive action: (b)(4) created a different style of assembly fixture to improve plunger assembly by fully seating the plunger.(b)(4) reviewed the change and observed more than 100 consecutive assemblies.No ill-fitting plunger assemblies occurred.(b)(4) will continue to perform random audits for the next 90 days.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

Customer reported that five or six syringes plungers would become crooked, causing a loss of seal in the syringe and allowing contrast to spill out.This has occurred over a three to six week period.

• Brand Name: POWER INJECTOR SYRINGE
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): COEUR, INC.; 209 creekside drive; washington NC 27889
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5847558
• MDR Text Key: 52650364
• Report Number: 1060680-2016-00019
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K832920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 77-400277
• Device Lot Number: IAFLQ1511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2016
• 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