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

Catalog Number 89-6896

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

An internal complaint (call (b)(4)) was received indicating that a cath pack (finished good (b)(4), lot number 41167851) contained syringes that have been cracking during use, allowing blood to squirt onto the staff.A sample was reported to be available, but as of the date of this report, it has not been returned.The work order was reviewed for discrepancies that may have contributed to the reported incident.None were identified.There are multiple syringes contained within the finished good kit.The reporting customer was contacted to identify the correct raw material.The customer confirmed the correct raw material is a 10cc syringe raw material (b)(4).This syringe is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request was submitted to (b)(4) on (b)(6) 2016.A response has not been received at this time.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

Some of the syringes in the pack have been cracking during use.This has caused situations in which a staff member pushes the barrel of the syringe to inject not knowing that the syringe is cracked, resulting in blood squirting out on the staff.The user facility considers this a safety concern.

Manufacturer Narrative

Root cause: the raw material in which the reported issue occurred is supplied to deroyal by (b)(4).Therefore, a supplier corrective action response (scar) was submitted to (b)(4).In its response, (b)(4) identified the root cause as a packaging-related issue.(b)(4) stated the syringes are shipped bulk non-sterile in cases of 1,000 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 500 or less and is being placed into smaller quantities in the case.Investigation summary: an internal complaint ((b)(4)) was received indicating that a cath pack (finished good 89-6896, lot number 41167851) contained syringes that have been cracking during use, allowing blood to squirt onto the staff.There are multiple syringes contained within the finished good kit.The reporting customer was contacted to identify the correct raw material.The customer confirmed the correct raw material is a 10cc syringe (raw material 5-20055).This syringe is supplied to deroyal (b)(4).A review of the 2015-2016 scar log identified previous reports for cracked syringes supplied by (b)(4).Therefore, a scar was submitted to (b)(4) on august 12, 2016.A response was received august 18.The actual sample was received august 19 and (b)(4) was notified regarding its availability.The work order was reviewed for discrepancies that may have contributed to the reported incident.None were identified.Deroyal will continue to monitor postmarket feedback for the reported issue and verification of the supplier's actions.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

Some of the syringes in the pack have been cracking during use.This has caused situations in which a staff member pushes the barrel of the syringe to inject not knowing that the syringe is cracked, resulting in blood squirting out on the staff.The user facility considers this a safety concern.

• Brand Name: CATH PACK CSM
• Type of Device: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5890275
• MDR Text Key: 52734630
• Report Number: 3005011024-2016-00021
• 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: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-6896
• Device Lot Number: 41167851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2016
• 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