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

Model Number 89-7420

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint (call (b)(4)) was received for a cardiac catheter tray (part # 89-7420, lot # 49330393) that contained a syringe with a hole.Blood was drawn into the syringe without issue, but when pushing blood back, it came out of a small hole in the side, exposing the physician to blood.A sample was returned july 2, 2019.The sample contained a small crack in the syringe that was difficult to notice.The work order was reviewed for possible discrepancies that may have contributed to the reported issue.The work order contained three different syringes.According to the reporting customer, the issue was with component 5-20055-taa -- a 10cc syringe supplied to deroyal by bd.This product comes to deroyal in bulk with syringes placed inside a poly bag in a box at 850 per case.The small crack reasonably could have been missed by deroyal kit assemblers.However, due to the nature of the report, retraining was performed with assemblers responsible for placing the syringe in the tray.The 2017-2019 supplier corrective action request (scar) and 2017-2019 supplier notification letter logs were reviewed for similar complaints.Similar complaints were identified and a scar was issued to bd.As of the date of this report, a response has not been received.The investigation is ongoing at this time.If and when additional information is received, this report will be updated.

Event Description

A cardiac cath pack contained a bd syringe that had a small hole.Blood was drawn into the syringe without issue, but when pushing the blood back, the blood came out a small hole in the side of the syringe.The physician was exposed to blood.

Manufacturer Narrative

Root cause: the syringe is supplied to deroyal by bd.Therefore, a supplier corrective action request was sent bd.In its response, bd stated it evaluated a photo as well as a returned sample, and a lengthwise crack approximately 1" in size was observed, extending from the "4" to the "8" on the marking scale.Cosmetic scuffs approximately 1/16" in size were noticed in various locations throughout the barrel.It also appeared there was foreign green matter particles inside and outside the barrel.It is possible the crack occurred during the assembly process.The small cosmetic scuffs indicate the syringe may have gotten caught for a period of time and was potentially a self-corrected issue.Corrective action: deroyal employees responsible for placing the syringe in the tray have been retrained on the internal work order processing procedure.In its scar response, bd stated only one defective syringe was reported with no other complaints related to the defect for the affected batch.Therefore, this is most likely an isolated incident.The aql for incorrect assembly is 0.65%.The defective rate identified is 1 out of 428,400, which is 0.0002%.No corrective actions are necessary based on the defective rate identified.Investigation summary an internal complaint (call 47479) was received for a cardiac catheter tray (part # 89-7420, lot # 49330393) that contained a syringe with a hole.Blood was drawn into the syringe without issue, but when pushing blood back, it came out of a small hole in the side, exposing the physician to blood.A sample was returned july 2, 2019.The sample contained a small crack in the syringe that was difficult to notice.The work order was reviewed for possible discrepancies that may have contributed to the reported issue.The work order contained three different syringes.According to the reporting customer, the issue was with component 5-20055-taa -- a 10cc syringe supplied to deroyal by bd.This product comes to deroyal in bulk with syringes placed inside a poly bag in a box at 850 per case.The small crack reasonably could have been missed by deroyal kit assemblers.However, due to the nature of the report, retraining was performed with assemblers responsible for placing the syringe in the tray.The 2017-2019 supplier corrective action request (scar) and 2017-2019 supplier notification letter logs were reviewed for similar complaints.Similar complaints were identified and a scar was issued to bd.A response was received august 1, 2019 and accepted by deroyal personnel.The investigation is complete at this time.If and when additional information is received, this report will be updated.

Event Description

A cardiac cath pack contained a bd syringe that had a small hole.Blood was drawn into the syringe without issue, but when pushing the blood back, the blood came out a small hole in the side of the syringe.The physician was exposed to blood.

• Brand Name: CARDIAC CATH PACK
• Type of Device: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 8800068
• MDR Text Key: 203636050
• Report Number: 3005011024-2019-00008
• Device Sequence Number: 1
• Product Code: OEQ
• UDI-Device Identifier: 00749756739702
• UDI-Public: 00749756739702
• Combination Product (y/n): N
• PMA/PMN Number: K842648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-7420
• Device Lot Number: 49330393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1