MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. EXTENSION SET; SET, ADMINISTRATION, INTRA

Catalog Number	470172
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: event 1: customer reports several incidences of primary set breaking off in the caresite on trying to remove the primary set.When the nurse went into the patient's room to disconnect her from her evening dose of antibiotics.Upon disconnecting the primary tubing from the patient the end piece broke off inside the connection tubing that was connected to the patient.The broken piece inside kept the flow open so blood was coming back out of the iv line.This rn had to disconnect the extension tubing from the cannula/ catheter and connect a new one.No injury reported.
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).No samples were returned for evaluation in connection with this incident.A review of the discrepancy management system (dsms) database was unable to be performed as the lot number was reported as unknown.Without the actual device or lot number, a thorough investigation could not 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.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• MDR Report Key: 8037423
• Report Number: 9614279-2018-00186
• Device Sequence Number: 1585165
• Product Code: FPA
• UDI-Device Identifier: 04046964580215
• UDI-Public: 04046964580215
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 470172
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1