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 07/15/2016

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.This was reported to have occurred in "5 or 6" syringes, and therefore, a total of five internal complaints were entered.The syringe is supplied to deroyal by (b)(4).A supplier corrective action request (scar) has been sent to the vendor.Samples were returned in connection with the initial complaint, which is associated with medical device report 1060680-2016-00019.These also were forwarded to coeur for evaluation.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

The plunger inside of the syringe became crooked, allowing contrast to leak out of the syringe.

Manufacturer Narrative

Root cause: the syringe is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request (scar) was submitted to (b)(4).In its response, the supplier stated the root cause cannot be determined due to a lack of information and defective samples.Corrective action: in its scar response, (b)(4) stated an awareness review was performed with employees.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.This was reported to have occurred in "5 or 6" syringes, and therefore, a total of (b)(4) internal complaints were entered.The syringe is supplied to deroyal by (b)(4).Samples were returned in connection with the initial complaint, which is associated with medical device report 1060680-2016-00019.These also were forwarded to (b)(4) for evaluation.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.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.None were identified.Preventive action: in its scar response, (b)(4) stated a different style of assembly fixture was created to improve plunger assembly by fully seating the plunger.The change was reviewed, and more than 100 consecutive assemblies were observed.No ill-fitting plunger assemblies occurred.(b)(4) intends to continue performing random audits over 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

The plunger inside of the syringe became crooked, allowing contrast to leak out of the syringe.

Manufacturer Narrative

Root cause: the syringe is supplied to deroyal industries by (b)(4).Therefore, a supplier corrective action request (scar) was issued to (b)(4).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 (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.This was reported to have occurred in "5 or 6" syringes, and therefore, a total of five internal complaints were entered.The syringe is supplied to deroyal by (b)(4).Samples were returned in connection with the initial complaint, which is associated with medical device report 1060680-2016-00019.These also were forwarded to (b)(4) for evaluation.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: in its scar response, (b)(4) stated a different style of assembly fixture was created to improve plunger assembly by fully seating the plunger.The change was reviewed, and more than 100 consecutive assemblies were observed.No ill-fitting plunger assemblies occurred.(b)(4) intends to continue performing random audits over 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

The plunger inside of the syringe became crooked, allowing contrast to leak out of the syringe.

• 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: 5873038
• MDR Text Key: 52104984
• Report Number: 1060680-2016-00022
• 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,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: No
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• 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: Initial
• Patient Sequence Number: 1