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

Catalog Number 385100

Device Problems Break (1069); Leak/Splash (1354)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 02/11/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Device evaluation: result - (b)(4) received one q-syte unit without packaging.The unit was in 2 portions: portion 1; the top body/septum of the q-syte and portion 2; the bottom body of the q-syte unit.A visual/microscopic evaluation was performed.Traces of a weld flash on the rims of the top and bottom body were observed.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 6153901.Conclusion - the defects leakage and weld joint separation were confirmed.The top and bottom body were separated at the weld joint location which created a path for leakage.Bd is unable to confirm the patient death.A definite source that contributed to the separation at the weld joint location could not be established.Although an inadequate weld flash was observed; the q-syte unit was in use for two days before the separation occurred.This provides evidence that there was an adequate weld between q-syte top and bottom bodies provided during the manufacturing process.The weld joint separation could have been introduced by external forces.

Event Description

It was reported that at 1500 on (b)(6) 2017, the patient was receiving a lower limb infusion.The bd q-syte¿ luer access split-septum stand-alone device was being used with an unknown non-bd brand sti and infusion set.The nurse found the suspect device broken at 1830 on (b)(6) 2017 and noted blood and medication had leaked from the connector.The medication being infused was methylprednisolone, mucosolvan, and avelox dissolved in 5% glucose saline.The middle part of the suspect device was found broken in two section.A new q-syte was immediately replaced and the infusion was continued.At this time, the patient's blood results were normal, vital signs steady, and the doctor estimated the blood loss to be about 30 ml.The patient died on (b)(6) 2017.The patient was initially hospitalized for copd but was not critically ill.Per report on (b)(6) 2017, "at present, the hospital did not identify the final death of patients but the hospital may be considered as a cause of cardiac disease." no additional information is available.

• 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: 6390346
• MDR Text Key: 69437862
• Report Number: 9610847-2017-00013
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 385100
• Device Lot Number: 6153901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/08/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death