MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; LUER ACCESS SPLIT SEPTUM

Catalog Number 385100

Device Problems Break (1069); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd q-syte¿ luer access split-septum stand-alone device was damaged on the surface.There was no report of exposure to mucous membranes, injury or medical interventions.

Manufacturer Narrative

Results: one sample unit from an unknown lot number was received for evaluation by our quality engineer team.Upon examination, the septum top disk was observed to be completely torn from the rim of the top body.Further analysis of the sample revealed evidence of residual septum material and adhesive deposits; an indication that a bond was provided during the manufacturing process.As no evidence was found to support manufacturing related issues for the reported defect, a root cause could not be determined.A review of the device history record could not be performed as no lot number was provided for this incident.The septum top disk was completely torn from the rim of the top body and the bottom portion of the septum.Residual septum material and adhesive deposits were observed on the rim of the top body.Investigation samples meet manufacturing specifications: no, the returned unit provided for evaluation displayed the septum top disk was completely torn from the rim of the top body and the bottom portion of the septum.Conclusions: the defect septum damaged/defective, as stated as the reported code was confirmed with the returned unit.Conclusion: the root cause is indeterminate.The evaluation of the septum/top body damage location revealed evidence of residual septum material and adhesive deposits.This is an indication that a bond was provided during the manufacturing process.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• Type of Device: LUER ACCESS SPLIT SEPTUM
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7137162
• MDR Text Key: 95748141
• Report Number: 9610847-2017-00200
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851004
• UDI-Public: 30382903851004
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other