MAUDE Adverse Event Report: B. BRAUN AVITUM ITALY S.P.A. PINNACLE®; CONTAINER, I.V.

Catalog Number	2112347
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2013017 b.Braun inc.(bbmi) (importer) is submitting the report on behalf of b.Braun italy s.P.A.(manufacturer).This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: pharmacist was compounding 8ml of nitroprusside (sagent mnfctr) into 234ml of dextrose 5 percent (baxter mnfctr), then added 8ml of sodium thiosulfate (hope pharmaceuticals).Prepared the infusion and sent to the nursing unit in an amber bag to protect from light until use.When the nurse removed the compounded bag from the amber bag, the eva bag was blue.The nitroprusside and sodium thiosulfate in d5 water solution turned blue; not the bag itself.No patient involvement.
Additional Manufacturer Narrative
Exemption number e2013017.(b)(4).One (1) filled bag was received for evaluation.The bag and the solution were visually inspected, and neither the bag nor the solution in the bag showed any blue discoloration.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: PINNACLE®
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): B. BRAUN AVITUM ITALY S.P.A.; via xxv luglio 11; mirandola 41037 ; IT 41037
• MDR Report Key: 8089126
• Report Number: 9681240-2018-00026
• Device Sequence Number: 13874015
• Product Code: KPE
• UDI-Device Identifier: 04046964200618
• UDI-Public: (01)04046964200618
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K041415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018
• Report Date (Section F): 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: 2112347
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/20/2018
• 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
• Date Report Sent to FDA: 12/20/2018