MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,CUFF,22MM ID; PRESSURE ACCCESSORY

Catalog Number 1421

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.

Event Description

The customer alleges the adaptor fails due to cracks in the adaptor.No patient injury or harm.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there were cracks on the product.The complaint cannot be confirmed based on the sample provided by the customer.There is no sufficient evidence to assure this issue was originated during the manufacturing process.The sample was not received in the original packaging, and a lot number was not provided.The root cause for the reported condition could not be identified.

Event Description

The customer alleges the adaptor fails due to cracks in the adaptor.No patient injury or harm.

• Brand Name: HUDSON ADAPTOR,CUFF,22MM ID
• Type of Device: PRESSURE ACCCESSORY
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5195618
• MDR Text Key: 30167437
• Report Number: 3004365956-2015-00330
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1421
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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