MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿CONNECTOR LUER LOCK C45

Catalog Number 515202

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem Chemical Exposure (2570)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Date received by manufacturer is used for this field.Device expiration date: unknown.Device manufacture date: unknown.Results: a sample is not available for evaluation.A review of the device history record and manufacturing process could not be performed as a lot number for this incident was not provided.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.

Event Description

It was reported that the suspect device had a leak where the luer-lock connector connects to the patient.The patient was receiving a one-hour infusion of etoposide (chemo agent).The nurse stayed with the patient for the first few minutes to make sure there were no complications.The patient called the nurse about 5-10 minutes after she left saying that her gown felt wet.It appeared that the luer-lock connector had come loose from the patient's line and was leaking onto the patient.The patient immediately had her soiled gown removed and her skin that was exposed was cleaned thoroughly and she was continually assessed for irritation or any changes.No medical interventions were provided.

Manufacturer Narrative

Additional information: age- (b)(6) years old; date of event: (b)(6) 2016 (date of notification updated to actual date of event); copied medwatch #(b)(4); description of events; medical device lot # 1601001, expiration date: 12/31/2019; device manufacture date: january, 2016.Device evaluation: results: (b)(4) retained samples for connector c45 and lot #1601001 were taken for evaluation.A microscopic inspection revealed no damages or defects.Luer taper and thread diameter were verified with pass/no pass gauge and all inspection results were acceptable for all retained samples.A review of the molding and assembly process revealed no abnormalities.A leak test was performed to ensure the quality and function of the device and no irregularities were observed.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 1601001.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customers indicated failure mode.

Event Description

Per medwatch report #(b)(4) event description as follows: "chemo orders previously checked by two chemo rns.Consent verified.169mg iv etoposide double checked by two chemo competent rns, drug vs original order vs patient using three positive patient identifies.Appropriate chemo precautions and ppe utilized.Right double lumen picc line flushed and aspirated with positive brisk blood return.Rn stayed with patient for first five minutes of infusion.Patient tolerating infusion without complication.After approximately 55 minutes, rn came in to check on patient.Patient complained that her pillow that her right upper extremity (rue) was resting on (extremity with dl picc) "esta mojado" (is wet).Rn felt wet pillow and realized it could be chemotherapy - immediately stopped the alaris pump.Rn aspirated from lumen where etoposide had been infusing, positive brisk blood return present.Rn then flushed from downstream port, some saline leaked out between the blue, luer lock blue clave and the smaller phaseal.Rn turned off pumps and got spill kit and called charge rn into room.Hydrogen peroxide ordered.Charge and bedside rn utilized chemo spill kit and disposed of soiled linen.Patient immediately washed affected skin with soap and water.Then washed with hydrogen peroxide.Linens changed.Rns estimated approximately 20-50 cc lost etoposide via spill.Picc line dressing, caps and tubing changed.".

Manufacturer Narrative

Report to fda: yes.This incident was notified by the user facility to the fda via medwatch (b)(4).

• Brand Name: BD PHASEAL¿CONNECTOR LUER LOCK C45
• Type of Device: CONNECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5770875
• MDR Text Key: 49507513
• Report Number: 3003152976-2016-00008
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 515202
• Device Lot Number: 1601001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/19/2016; 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 67 YR