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

Catalog Number	1121
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); No Information (3190)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
It was reported that the patient's year of birth was (b)(6).The exact date is unknown.
Event or Problem 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
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6634867
• Report Number: 3012307300-2017-01247
• Device Sequence Number: 18835242
• Product Code: CCK
• UDI-Device Identifier: 10610586038266
• UDI-Public: 10610586038266
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K864902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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
• Operator of Device: No Information
• Device Catalogue Number: 1121
• Device Lot Number: 050916
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 75