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

Catalog Number	NF5145
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as event one of b.Braun medical inc.Internal report # (b)(4).The sample was tested for leakage at 10 psi per specification and failed.There was leakage observed from the bonded joint of the top cap and tubing of the pump housing assembly.The defect was confirmed and attributed to the cap not being seated correctly on the tubing.Bbmi determined the most probable root cause of the leakage was due to an angled cut in the tubing, which led to the cap not being fully seated.A supplier corrective action notice (scan) has been issued to the manufacturer of the tubing in order to further investigate issues related to irregular or angled cut tubing.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 1: after spiking the unit of blood and priming the intravenous (iv) line, the anesthesiologist began pumping the tubing with his hand at the "hand pump" site.When he did this, blood leaked out of the top of the hand pump site.

• Brand Name: BLOOD ADMINISTRATION 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, dominican republic ; DR
• MDR Report Key: 6109285
• Report Number: 9614279-2016-00080
• Device Sequence Number: 672654
• Product Code: FPA
• UDI-Device Identifier: 04046964187506
• UDI-Public: (01)04046964187506(17)190331(10)0061361992
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K840212
• 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): 12/17/2014

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: 03/31/2019
• Device Catalogue Number: NF5145
• Device Lot Number: 0061361992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2014
• Initial Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1