MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. HEART CATH PACK; ANGIOGRAPHY/ANGIOPLASTY KIT

Catalog Number 89-7425

Device Problems Crack (1135); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

Root cause analysis: the sample was not returned to deroyal for evaluation.Therefore, a true root cause cannot be determined.Potential root causes have been identified but are not limited to the following: mishandling of the device caused a crack that was undetected prior to use; or vendor manufacturing related issue.Corrective action and/or systemic correction action taken: due to the investigation and root cause determination, a corrective action has not been taken.Investigation summary: a complaint (call (b)(4)) was received reporting that a heart cath pack (part number 89-7425, lot number 38923207) contained a syringe that cracked during administration of medication.A sample was not returned for evaluation.Without a sample, a true root cause cannot be determined.It cannot be confirmed if the issue occurred due to the raw material supplier, manufacturing, or end user.Deroyal made multiple attempts to obtain the sample for evaluation, but a sample was never received.The bill of materials for the finished good contained multiple syringes.Therefore, the qc complaint specialist followed up with the reporting customer, who responded identifying the issue occurred with the 10cc luer lock syringe (raw material(b)(4)).Using the lot mapping feature in (b)(4), the qc complaint specialist confirmed that lot number 39823207 of the heart cath pack contained lot number 15135071 of the raw material 10cc luer lock syringe.The work order was reviewed for discrepancies that may have contributed to the reported issue, but no discrepancies were identified.Multiple vendors supply raw material (b)(4) to deroyal.Quality control at the manufacturing facility identified the supplier as (b)(4).The 2013 to 2015 supplier corrective action request (scar) and supplier notification letter (snl) logs were reviewed for similar complaints.No similar complaints were identified for the raw material or failure mode reported.Due to the failure reported, the qc complaint specialist issued a scar to (b)(4) for notification of the report.Deroyal has not received a response to the scar.The complaint investigation will be reviewed for updates when the response is received.Deroyal has sold (b)(4) each of raw material (b)(4) from 2013 to present.The complaint to sales ratio is (b)(4).Deroyal will continue to monitor trends for this failure and will recognize in the future if it transitions into a recurring issue.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is complete.If new and critical information is received, this report will be updated.Device not returned to manufacturer.

Event Description

A 10 ml syringe inside the pack cracked when medication was pushed.The procedure was delayed while they had to change syringes and redraw medication.No injury was reported medication was wasted from cracked syringe.

Manufacturer Narrative

Root cause analysis: the raw material in which the reported issue occurred is supplied to deroyal by (b)(4) in response to a supplier corrective action response (scar) received august 12, 2016, (b)(4) identified the root cause of cracking-related failures to be a packaging-related issue.(b)(4) stated the syringes are shipped bulk non-sterile in cases of (b)(4) units.There have been reports in the past of the product cracking upon receipt.(b)(4) believes this issue is related to the packaging, which is making the product weak during the shipping process.Corrective action: in its scar response, (b)(4) stated the product now is being packaged in lower quantities of (b)(4) or less and is being placed into smaller quantities in the case.Investigation summary: a complaint (call 3(b)(4)) was received reporting that a heart cath pack (part number 89-7425, lot number 38923207) contained a syringe that cracked during administration of medication.The bill of materials for the finished good contained multiple syringes.Therefore, the qc complaint specialist followed up with the reporting customer, who responded identifying the issue occurred with the 10cc luer lock syringe (raw material (b)(4)).Using the lot mapping feature in jd edwards, the qc complaint specialist confirmed that lot number 39823207 of the heart cath pack contained lot number 15135071 of the raw material 10cc luer lock syringe.Multiple vendors supply raw material (b)(4) to deroyal.Quality control at the manufacturing facility identified the supplier as (b)(4).Evaluation of the 2015 to 2016 scar log identifies multiple reports of cracked syringes supplied by (b)(4).A scar request was issued to (b)(4), and a response was received august 18, 2016.A sample was not returned for the reported incident.The work order was reviewed for discrepancies that may have contributed to the reported issue, but no discrepancies were identified.Deroyal has sold (b)(4) each of raw material (b)(4) from 2013 to present.(b)(4).Deroyal will continue to monitor postmarket feedback for the reported issue and verification of the supplier's actions.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is complete.If new and critical information is received, this report will be updated.Device not returned to manufacturer.

Event Description

A 10 ml syringe inside the pack cracked when medication was pushed.The procedure was delayed while they had to change syringes and redraw medication.No injury was reported medication was wasted from cracked syringe.

• Brand Name: HEART CATH PACK
• Type of Device: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL LNDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5202336
• MDR Text Key: 30458952
• Report Number: 3005011024-2015-00011
• Device Sequence Number: 1
• Product Code: OEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-7425
• Device Lot Number: 39823207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2015
• 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