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

Catalog Number	NF9100
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
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: it was reported that the pharmacy staff have noticed that when utilizing the 9f90100 safeline injection port with a needle, the injection port is coring and a particulate forms in the solution.The customer was informed that the safeline 9f90100 is a needleless injection port with a split septum and that the recommended product to use to access the port is safeline clip lock cannula (nf9200).Customer was informed that the device is not designed to be used with a needle and should be paired with the recommended device(s).No patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One 1000 ml bag of sodium chloride was returned for this complaint.No samples of item nf9100 were returned.Although the "defective" device was not retruned, it was stated that the safeline injection site was being used with a needle.B.Braun's ifu recommends a safeline cannula for this product.This report has confirmed as user error/wrong handling.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: SAFELINE®
• 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: 8484464
• Report Number: 9614279-2019-00040
• Device Sequence Number: 1723909
• Product Code: FPA
• UDI-Device Identifier: 04046964187520
• UDI-Public: 04046964187520
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K931377
• 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): 06/19/2019

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: NF9100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1