MAUDE Adverse Event Report: B. BRAUN DOMINICIAN REPULIC INC. CARESITE®; SET, ADMINISTRATION, INTRA

Catalog Number 470117

Device Problem Fluid/Blood Leak (1250)

Patient Problem Venipuncture (2129)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Multiple unsuccessful attempts were made to obtain a sample.During a follow up with the facility, it was confirmed that the sample is not available for further evaluation.Without the actual device and/or lot number a thorough investigation was unable to be performed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

Event Description

As reported by the user facility: it was reported that blood leaked during patient therapy.Upon rounding on patient to evaluate central line it was noted that blood was backed up in tubing.The tubing was examined and noted to be behind patient's back.After repositioning patient it was noted that tpn line had broken in half at an area of a y site.The tpn was infusing into the bed.It is unknown how long this had been happening, however the entire top of the bed was saturated in tpn and blood.The central line (tlc) that the tpn was infusing into was replaced the next day.

• Brand Name: CARESITE®
• Type of Device: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 9295125
• MDR Text Key: 166184860
• Report Number: 9614279-2019-00202
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964183997
• UDI-Public: 04046964183997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942988
• 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: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 470117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2019
• 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