MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number 8888160341

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According the reporter the product lines have been cracked prior to use.

Manufacturer Narrative

An investigation of the reported condition was performed.A device history review (dhr) revealed no discrepancies that may have contributed to the reported condition.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.Five used single uvc catheters and one dual uvc catheter was received for testing and investigation.The samples contain blood residue inside the tubing.Additionally, the samples were received inside of a generic bag.A visual inspection of the catheters was performed and revealed that: sample 1: the tubing was broken approximately 0.5¿ below the strain relief.Sample 2: the catheter did not present any problem; also the catheter was tested under water without any problem as result.Sample 3: the tubing was broken approximately 4.5¿ below the strain relief.Sample 4 and 5: the tubing was broken below the strain relief.Sample 6: this catheter is a dual and did not present any problem.All of the catheters that were broken were magnified and photographs were taken.After viewing the magnified photos of the samples, irregular cuts were observed in the location of the broken catheter.Post manufacturing damaged of the device occurred.The product uvc dfmea (device failure mode and effective analysis) was reviewed.Based on the available information, it can be concluded that product was manufactured according to specifications; therefore the most probable root cause can be considered as unintentional misuse; this condition was most likely damaged during use caused due to the product coming into contact with a sharp instrument by the user.A corrective and preventive action (capa) is not deemed necessary at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6914820
• MDR Text Key: 88209980
• Report Number: 3009211636-2017-05315
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 10884527005123
• UDI-Public: 10884527005123
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2022
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: 1706700104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 09/06/2017
• Supplement Dates FDA Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1