MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. VASCULAR UNKNOWN

Catalog Number VASCULAR UNKNOWN

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was transferred from another facility with a triple lumen pressure injectable cvc in their internal jugular.When changing the dressing in the icu they noticed a small pinhole in the medial lumen.As a result, the catheter was removed and a new form of access was used.There was no delay in treatment and no patient death or complications reported.

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint was confirmed through examination of a returned product sample.The customer provided a 3- lumen catheter with signs of use.Microscopic examination revealed dents from clamps in all three extension lines and a small cut in the medial extension line at 8.7 cm below the luer hub base.No other damage was observed.The catheter was leak tested and exhibited leakage at the cut in the medial extension line immediately.The product number and lot number were not provided.Manufacturing records could not be reviewed.And although the product is unknown, instructions for use provided with similar products caution not to use scissors to remove dressing to minimize the risk of cutting the catheter.Based on the time of discovery and the damage observed to the catheter it was determined that operational context caused or contributed to this complaint.No further action will be taken.

• Brand Name: VASCULAR UNKNOWN
• Type of Device: VASCULAR UNKNOWN
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5145599
• MDR Text Key: 28476668
• Report Number: 1036844-2015-00477
• Device Sequence Number: 1
• Product Code: DQO
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 10/05/2015

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 Catalogue Number: VASCULAR UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• 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