MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. IV ADMINISTRATION SET; SET, ADMINISTRATION, INTRA

Catalog Number	490368
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report # (b)(4).One used iv administration set was received for evaluation.Packaging returned with the set indicated the reported lot number.The set was subjected to leakage testing according to our internal specification.During this testing, leakage was observed at the bonded joint between the stopcock and manifold connection.A potential cause identified was that insufficient solvent in combination with an incomplete insertion of the stopcock may have been applied at this joint during the manual assembly of the set.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.However, bbmi has shared this reported event with all applicable supervisors and personnel involved with the manufacturing and inspection of this product to ensure awareness of this event and failure mode reported from the field.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.If additional pertinent information becomes available, a follow-up report will be filed.Note: this case is being filed retrospectively as a result of a review of recent customer complaint information.Based on additional information and details provided in another complaint case, it was determined that this case is reportable in accordance with the requirements of 21 cfr 803.B.Braun has conducted a retrospective review for all complaints of a similar nature in accordance with internal procedure (b)(4).
Event or Problem Description
As reported by the user facility: event # 2: reports that after priming the iv tubing the roller clamp is closed.However, the tubing continued to flow from the triple stopcock area of the set to the luer lock ending.Therefore, the set was not completely primed.

• Brand Name: IV ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6112792
• Report Number: 2523676-2016-00728
• Device Sequence Number: 1168729
• Product Code: FPA
• UDI-Device Identifier: 04046964669927
• UDI-Public: (01)04046964669927(17)170131(10)0061419942
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K111016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2015

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 Expiration Date: 01/31/2017
• Device Catalogue Number: 490368
• Device Lot Number: 0061419942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2015
• Initial Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1