MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 30 CM; ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number CV-14703

Device Problems Air Leak (1008); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the puncture of the patient's left jugularis in the surgical icu, it was noted that air was aspirated.A leak was found at the cone of the needle.As a result, a new kit was opened and used without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).The report was reviewed; however, a comprehensive investigation could not be performed because no sample was returned for analysis.A device history record review could not be performed since a lot was not reported and sales history data was not available for this customer.The potential cause could not be determined based upon the information provided and without a sample.No further actions will be taken.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the reported event was confirmed through examination of a returned product sample.The customer provided an introducer needle with one longitudinal crack running through the length of the hub.The luer taper was found to be within specification via gage testing.A device history record review was performed with no relevant findings.The probable cause of this issue could not be determined.Further investigation has been initiated with the spec developer.The previous follow-up report indicated that no sample was available for evaluation.A device has since been received and the investigation was reopened.

• Brand Name: CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: ADULT MULTI LUMEN CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5344560
• MDR Text Key: 35077952
• Report Number: 3006425876-2016-00003
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: CV-14703
• Device Lot Number: 71F15C1596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2015
• 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