MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH; UMBILICAL VESSEL CATHETER

Model Number 8888160333

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/22/2016.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an umbilical vessel catheter.The customer states that the catheter was inserted in, soon after admission around 11:00 the nurse apparently pulled on the catheter then it broke leaving a section behind the patient.The patient was harmed and the surgical time was extended by more than 30 minutes.The patient needed an extra procedure done to have the broken piece removed.The amount of blood loss is unknown.The patient was (b)(6) old at the event and weighed (b)(6).The baby went home on (b)(6) 2016 in a stable and satisfactory condition.Several x-rays were done including abdominal and lateral shoot through to establish exactly the location of the remainder of the line.Baby went to theatre on (b)(6) 2016 and the rest of line was removed via umbilicus.The patient was on ampicillin and gentamycin prophylactic antibiotics prior and post theatre and perfalgan 60mg ivi x4 was given for pain post op ivi.The cord was clean as usual with chlorexidene and alcohol before insertion of line and none after insertion.Heparin and saline was used to keep line patent during and after insertion.

Manufacturer Narrative

An investigation of reported condition was performed.One used sample was returned for evaluation and further investigation.The review of device history record(dhr) could not be performed without a lot number.The device history record¿s (dhr) was reviewed prior to it¿s product release.The possible root cause of the reported condition was identified by ishikawa diagram which indicated the defective material, customer misuse(unintentional) operator failed to follow process or inspection procedures, machine, method and measurement related.All these causes were discarded and the potential root cause was determined to be customer manipulation(misuse).The reported condition was confirmed.The returned sample was sent to the manufacturing site for review.Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for a period of time.No corrective and preventive actions is deemed necessary at this time.The in -process controls such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the manufacturing plant to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.Should the customer provide additional information, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that the catheter was inserted in, soon after admission around 11:00 the nurse apparently pulled on the catheter then it broke leaving a section behind the patient.The patient was harmed and the surgical time was extended by more than 30 minutes.The patient needed an extra procedure done to have the broken piece removed.The amount of blood loss is unknown.The patient was (b)(6) at the event and weighed (b)(6).The baby went home on (b)(6) 2016 in a stable and satisfactory condition.Several x-rays were done including abdominal and lateral shoot through to establish exactly the location of the remainder of the line.Baby went to theatre on (b)(6) 2016 and the rest of line was removed via umbilicus.The patient was on ampicillin and gentamycin prophylactic antibiotics prior and post theatre and perfalgan 60mg ivi x4 was given for pain post op ivi.The cord was clean as usual with chlorexidene and alcohol before insertion of line and none after insertion.Heparin and saline was used to keep line patent during and after insertion.

• Brand Name: 3.5FR URETHANE UMB CATH
• Type of Device: UMBILICAL VESSEL CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6186069
• MDR Text Key: 63127454
• Report Number: 3009211636-2016-00503
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 DA
• Patient Weight: 4