MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 4-LUMEN 8.5FR X 16CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number UK-42854-MSB

Device Problem Crack (1135)

Patient Problem Air Embolism (1697)

Event Date 12/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information: this product is not sold in the us.The 510k # provided is for a similar product that is sold in the us.No sample will be returned for evaluation.

Event Description

It was reported by the doctor that a serious incident occurred today with regards to a likely air embolism in the unit on a patient who went profoundly hypoxic after a cvc insertion.The cxr post procedure did not reveal a pneumothorax and hence we resorted to a ttecho.The echo revealed lots of 'air bubbles' in the right heart.We did manage to aspirate about 10 - 20 mls of air out of the 200 mls of blood drawn up in the syringes.His hypoxia got better, as did the murmur that disappeared post aspiration.Although there might be other causes contributing to his hypoxia, he did have a very suggestive (of air embolism) picture that improved with 'textbook' aspiration via cvc.We will be doing a (b)(6) alert - given the 'white' bung has a hole in the middle.The other 'blue' bungs do not have any holes (as normally happens)." the doctor pointed out that the standard cvc set used on the unit did not have any of the white vented caps only the blue caps and the difference between this and the set included in the msb pack could give rise to confusion.The doctor also indicated that in his view, this incident was not solely attributable to the arrow product.

• Brand Name: CVC KIT: 4-LUMEN 8.5FR X 16CM
• Type of Device: ARROWG+ARD 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: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 6173365
• MDR Text Key: 62335147
• Report Number: 3006425876-2016-00391
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: UK-42854-MSB
• Device Lot Number: 71F16K1890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2016
• 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
• Patient Outcome(s): Required Intervention