MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-44K DISP PUNCH 4.4MM

Catalog Number DP-44K

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 03/18/2015

Event Type  malfunction  

Event Description

Alleged event: does not punch hole in the vein properly.The patient's condition was listed as unk.

Manufacturer Narrative

Qn#: (b)(4).The device sample has not been returned to the mfr for investigation at the time of this report.The mfr will continue to monitor and trend related events.

• Brand Name: PU DP-44K DISP PUNCH 4.4MM
• Type of Device: NI
• Manufacturer (Section D): TELEFLEX MEDICAL; rtp NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo, 8827 5; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4651086
• MDR Text Key: 5758630
• Report Number: 3004365956-2015-00113
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: DP-44K
• Device Lot Number: 74D1401104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: No
• Patient Sequence Number: 1