MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI® CANNULA SAMPLE LINE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Catalog Number 1121

Device Problem Material Integrity Problem (2978)

Patient Problems Partial thickness (Second Degree) Burn (2694); No Information (3190)

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the event occurred in (b)(6) 2017.The exact date is unknown.Device expiration date was unable to be determined with the information provided.Device manufacturer date was unable to be determined with the information provided.It was reported that a "serious adverse event" occurred, however, no details on the adverse event were provided.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that the wire of a bci® cannula sample line became exposed during use.It was reported that a "serious adverse event" occurred, however, details of the adverse event were not provided.Additional information regarding the event has been requested, but not yet received.

Manufacturer Narrative

It was reported that the patient's year of birth was (b)(6).The exact date is unknown.

Event Description

It was additionally reported that the cannula "combusted", and the patient sustained a superficial second-degree burn in the nasal tip, left nasal wing, and left "nasogenian" groove, corresponding to approximately 0.5% of the body surface according to medical criteria.In the same surgical procedure, debridement was performed and covered with duoderm.Patient required nine healing sessions until favorable evolution.The patient received the following treatments: (b)(6) 2017: duoderm was used for healing.No signs of infection were evident.(b)(6) 2017: evidence of epithelialization of 60%.Application of epithelial growth factor and an ultrasound were performed.(b)(6) 2017: evidence of epithelialization of 80%.New therapy with epithelial growth factor.(b)(6) 2017: evidence of epithelialization of 90%.Excoriation by removal of "micropore" in lower eyelid.Epithelial growth factor and hyaluronic acid were applied.(b)(6) 2017: evidence of epithelialization of 95%.Complete epithelization in the nostril and "nasogenian" groove.Epithelial growth factor and hyaluronic acid were applied.(b)(6) 2017: evidence of epithelization of 100%.Epithelial growth factor and hyaluronic acid were applied with electroporation.Patient left with tegaderm.(b)(6) 2017: adequate epithelialization.Cream therapy with epithelial growth factor.(b)(6) 2017: healing with complete epithelization.Hyperemic burn with good evolution.Therapy was performed with moisturizer.(b)(6) 2017: last treatment, with complete epithelization.The patient was discharged without showing functional or aesthetic sequelae.

• Brand Name: BCI® CANNULA SAMPLE LINE
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL OAKDALE; 3350 granada avenue north; suite 100; st. paul MN 55128
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6634867
• MDR Text Key: 77363335
• Report Number: 3012307300-2017-01247
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586038266
• UDI-Public: 10610586038266
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K864902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1121
• Device Lot Number: 050916
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 75