MAUDE Adverse Event Report: CAREFUSION 20 INCH EXT SET; INTRAVASCULAR ADMINISTRATION SET

Model Number C20022

Device Problem Leak/Splash (1354)

Patient Problem Missed Dose (2561)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Weight: (b)(6) kilograms.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that 20 inch ext set broke off in the lumen of the picc line.The following information was provided by the initial reporter: material no: c20022 , batch no: 20056787.It was reported that the tip of the tubing broke off in the lumen due to difficulty removing extension sets.Customer response 31-aug-2020: "the male piece from the extension tubing broke off in the picc line.Please see my responses to your questions below: additionally please advise on the additional inquiry regarding the adverse event: could you provide confirmation that the line was a central line and not a peripheral line? additionally, did it need to be replaced? this was a picc line which had to be removed; we placed a peripheral iv as the patient¿s antibiotic therapy was not completed.Pt had 3 more days of antibiotic therapy.Because the medication regimen was completed 3 days early, were any doses of medication missed? this is not accurate.The patient¿s medication regimen was not complete¿pt.Had 3 more days of therapy." customer response 25-aug-2020: are you able to provide a part no and batch no for the reported extension tubing? ref# c20022, lot# (10)20056787.Was there any adverse event(s) as a result of the reported defect? yes pt.¿s picc line had to be removed prematurely" event information: date of occurrence: (b)(6) 2020.What type of catheter securement was utilized? statlock.A more detailed description of the event: the patient¿s extension tubing was being changed out, and when the nurse tried to disconnect tubing from the lumen, the tip of the tubing broke off in the lumen.Since switching to bd tubing and extensions, staff have noticed that it is difficult to remove extension sets during dressing changes.Iv therapy¿s staff is very aware of alcohol dry time, so this most likely is not the cause.Staff have commented that all patients who have extension added to their lines are having difficulty removing the tubing¿some have had to use tourniquets to grip.Was the bard product used on a patient?: the bd product was used.Was there patient harm reported?:no, however, the patient¿s picc line had to be removed 3 days before treatment regimen completed.What they¿re being treated for: right calcaneal osteomyelitis ((b)(6)).Other relevant history: no other medical history.Concomitant therapy: n/a.

Event Description

It was reported that 20 inch ext set broke off in the lumen of the picc line.The following information was provided by the initial reporter: material no: c20022, batch no: 20056787.It was reported that the tip of the tubing broke off in the lumen due to difficulty removing extension sets.Customer response (b)(6) 2020: "the male piece from the extension tubing broke off in the picc line.Please see my responses to your questions below.Additionally please advise on the additional inquiry regarding the adverse event: could you provide confirmation that the line was a central line and not a peripheral line? additionally, did it need to be replaced? this was a picc line which had to be removed; we placed a peripheral iv as the patient¿s antibiotic therapy was not completed.Pt had 3 more days of antibiotic therapy.Because the medication regimen was completed 3 days early, were any doses of medication missed? this is not accurate.The patient¿s medication regimen was not complete.Pt had 3 more days of therapy." customer response (b)(6) 2020: are you able to provide a part no and batch no for the reported extension tubing? ref (b)(4), lot# (10)20056787.Was there any adverse event(s) as a result of the reported defect? yes pt.¿s picc line had to be removed prematurely".Event information date of occurrence:(b)(6) 2020.What type of catheter securement was utilized? statlock.A more detailed description of the event: the patient¿s extension tubing was being changed out, and when the nurse tried to disconnect tubing from the lumen, the tip of the tubing broke off in the lumen.Since switching to bd tubing and extensions, staff have noticed that it is difficult to remove extension sets during dressing changes.Iv therapy¿s staff is very aware of alcohol dry time, so this most likely is not the cause.Staff have commented that all patients who have extension added to their lines are having difficulty removing the tubing.Some have had to use tourniquets to grip.Was the bard product used on a patient? the bd product was used.Was there patient harm reported? no, however, the patient¿s picc line had to be removed 3 days before treatment regimen completed.What they¿re being treated for: right calcaneal osteomyelitis (mrsa).Other relevant history: no other medical history.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, d.10 returned to manufacturer on: 08/31/2020.Investigation conclusion: it was reported that the male piece from the extension tubing broke off in the picc line.Received from the customer is one used extension model c20022, lot 20056797.Attached to the set¿s female luer is a maxzero connector model mz1000-07 lot unknown.The set was visually inspected for cracks, misassemblies or damages to the components.Visual inspection found that the male luer (p/n 600117) tip of the set was broken off.Closer inspection under a lab microscope observed stress marks at the break site.No tool marks were observed.Equipment used for testing on 21sep2020: optical ram-cnc eq 08204 5-feb-21.A device history record for model c20022 with lot number 20056797 was performed.The search showed that a total of 12,099 units in 1 lot number were built on 25may2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The customer¿s report that the male piece from the extension tubing broke off was confirmed.The root cause of the break is due to excessive outside force on the male luer as indicated by the visible stress marks observed on the broken male luer tip.The root cause of the outside force could not be determined.

• Brand Name: 20 INCH EXT SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10486232
• MDR Text Key: 205499219
• Report Number: 9616066-2020-02629
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235498
• UDI-Public: 10885403235498
• Combination Product (y/n): N
• PMA/PMN Number: K790108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2023
• Device Model Number: C20022
• Device Catalogue Number: C20022
• Device Lot Number: 20056797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: C20022, 20200803, MZ1000-07; C20022, 20200803, MZ1000-07; C20022, 20200803, MZ1000-07
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR