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

Catalog Number	2112348
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sprain (2083)
Type of Reportable Event	Serious Injury
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: the facility has continual product use with repetitive spiking, constant elbow movement, hand and wrist twisting.The concern with spiking this bag is that the spike port needs to be spiked deeper or it will occlude.Pushing the spike in deeper repetitively is causing strain on employees all day long.One employee in particular experienced right elbow pain and numbness in her hand.Physical therapy was tried, but the discomfort continued.Eventually this employee needed surgery.Employee had an ulnar nerve right elbow neuroplasty on (b)(6) 2018.
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 actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.Although no samples were returned, samples were pulled from stock to test the force required to insert the universal spike in the bag port.The analysis of the data indicates that the insertion force values required to insert the universal spike into the single chamber bags have met the iso 15747:2010 specification.A total of 30 containers were tested, and the max force required for insertion from 28mm was 96.50 newton.The maximum allowable force per the iso standard is 200 newton, therefore the specifications have been met and no further action is required.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.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: 7494760
• Report Number: 9681240-2018-00004
• Device Sequence Number: 1417354
• Product Code: KPE
• UDI-Device Identifier: 04046964200670
• UDI-Public: (01)04046964200670
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K041415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2018
• Report Date (Section F): 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2112348
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/10/2018
• Event Location: Other
• Date Report to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Weight: 60
• Date Report Sent to FDA: 06/27/2018