MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL ¿SECONDARY SET C61; SECONDARY ADMINISTRATION SET

Catalog Number 515302

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd phaseal ¿secondary set c61 leaked during use.The nurse got several drops on her hands, but there was report of serious injury or medical interventions.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.

Event Description

It was reported that a bd phaseal secondary set c61 leaked during use.The nurse got several drops on her hands, but there was no report of serious injury or medical interventions.

Event Description

It was reported that a bd phaseal ¿secondary set c61 leaked during use.The nurse got several drops on her hands, but there was no report of serious injury or medical interventions.

Manufacturer Narrative

Investigation conclusion: one sample was received for investigation.The sample was visually inspected.Functional testing was conducted on the sample as well, underwater leak test, sample failed the test, leakage was observed on the location tube- spike.In collaboration with flks, potential root causes are being investigated.Relabeling activity that took place was carried out on packaging department since blister packaging was not opened.Marked with red square sticker is placed on top of existing text to correct manufacturing and expiration dates.Since c61 can only be sterilized once possibility existed that this lot was sterilized twice.For this lot when it come from distribution center new po was opened 1007443 there is no record of sterilization for lot 1007443 only for 1005467.Dispenser checkup is performed on the start of each lot of c61 to check the functionality of all parts of dispenser.A complaint history check was performed and this is the 5th related complaint reported with the defect/condition of leakage-other with lot #1005467 regarding item #515302.Additional 30 samples have been received to aid the investigation since all complaints for leakage on c61 product leakage locations reported are spike joint and spike tube joint for lot 1005467.Visual inspection was conformal no visual indications of failure or issue.Functional testing on air leak tester - all samples failed.Functional testing on underwater leak - all samples passed.Reason for inconsistency is that samples have come from the customer they have spent lot of time coiled and they won¿t retain the coiled position.This state affects leak tester that detects movement of air molecules inside the testing sample.This is ok for test implanted in production since sets are first tested coiled.Underwater test in this case is more reliable since it does not need the samples to remain still during testing.Sample that was leaking and 30 additional samples were sent to franklin lakes for ct scan.Ct scan results of two samples found defect in spike port of sample a (failed water leakage test).No defect in sample b (passed water leakage test).Investigation conclusion: ncr raised to address relabeling activity.Lot 1005467 was only sterilized once.Of all samples received only one was defective.Air leak test showed all samples as defective.Underwater leak test showed one defective sample.The inconsistency is due to coiled form of the sample received.Ct scan of the leaking and no-leaking sample is showing molding issue with the spike component of c61 and the part where tubing is inserted in spike.Additional testing on 2 other affected lots reveals no leakage defects.Defect on spike port - ct scan is showing lack of centricity of lower part of spike component and hole on spike port.Root cause of leakage on c61 is molding issue with spike component lower part of spike where tubing is connected is not centric, this defect will make wall of component thinner on one side an thus cause leakage.Correction: event description corrected to: it was reported that a bd phaseal ¿secondary set c61 leaked during use.The nurse got several drops on her hands, but there was no report of serious injury or medical interventions.

• Brand Name: BD PHASEAL ¿SECONDARY SET C61
• Type of Device: SECONDARY ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7475622
• MDR Text Key: 107508072
• Report Number: 2243072-2018-00208
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 515302
• Device Lot Number: 1005467
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other