MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. IV ADMINISTRATION SET; STOPCOCK, I.V. SET

Catalog Number US1275A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

(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.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.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.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 Description

As reported by user facility: reports iv tubing came apart during case and there was bleeding to the floor.Anesthesiologist and circulator were not aware of the disconnection and a considerable amount of blood was lost to the patient when noticed.Physician ordered hgb.Patient remained stable and had no ill effects from the blood loss and was discharged from the facility.No patient injury.

• Brand Name: IV ADMINISTRATION SET
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR
• Manufacturer Contact: eric roden ; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR ; 5491000
• MDR Report Key: 6133495
• MDR Text Key: 61098389
• Report Number: 9614279-2016-00111
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 04046964187957
• UDI-Public: (01)04046964187957(17)180304(10)0061484706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2018
• Device Catalogue Number: US1275A
• Device Lot Number: 0061484706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1